Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004196040

FEI Number

3004196040

Entity Name

SYMMETRY MEDICAL THORNTON PRECISION COMPONENTS LTD

City/State/Country

SHEFFIELD, SOUTH YORKSHIRE Barnsley, GB

Establishment Address

BEULAH ROAD, SHEFFIELD, SOUTH YORKSHIRE Barnsley S6 2AN, GB

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Tecomet (Owner Number: 1828464)

Owner / Operator Contact Address

170 New Boston Street, --, Woburn, MA 01801, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Empowr 3D SCP Guide Wire Sleeve 1.4mm T30 CANNULATED DRIVER, WITH 1/4" SQ CONECTOR AFFINITI EH2 52MM TUBEROSITY REAMER Bone Holding Forceps, Verbrugge FEM HINGE ALGNR MOST Aequalis Humeral Nail Case Upper Tray APR 19MM TROCHANTER BURR N-K II PARALLEL PATELLA C CFP QUICK LAUNCH 1 LAG SCREW CADDY LATITUDE EV INSTRUMENT CASE 1 Solid Hex Driver Top Stabilizer HRIS System Anchor Depth Gauge Handle Assembly Bone Hook RMR HOUSINGS, ROTATING PL PAT INSR ASSY MOST MIS DISTAL TELESCOPING ROD Aequalis Humeral Nail Case Outer 1 Wave Lag Screw Caddy Cannulated Drill Bit ITST Fixation STAYFUSE SEPARATOR INSTRUMENT STEM ALIGNMENT GUIDE Wave Non Locking Fully Threaded Screw Caddy AFFINITI EH2 INSTRUMENT BASE Distal Guide HTO "Z" RETRACTOR MACHINE TIBIAL DEPTH RESECTION STYLUS Wave Locking Screw Caddy Affiniti EH2 Instrument Lid BOM Aequalis Humeral Nail Case Lid1 GMRS DJO Surgical Acetabular Retractor Offset Shell Inserter A/P SIZER, TOWER DJO Surgical Bone Hook Wave Case Base Insert AEQUALIS REV. II REAMER CASE ASSEMBLY Affiniti EH2 Instrument Tray BOM CUT GUIDE TELESCOPING ROD FEM LOCKING PIN INSR/EXT Wave Plate Locking Screw Caddy Insert CFP QUICK LAUNCH SCREW CADDY (LOCKING SCREWS) LATITUDE QLS PRIMARY CASE - HUMERAL Wave Plate Caddy T-HANDLE ZIMMER CHUCK PROX FEM RULER MOST SLOTTED NOTCH GDE SZ AB MTO 7x11 tray ArthroCare, Tray, Box, and Bag Ascend Modular Reverse Instrument Case ART SURF REMOVAL INST FEM SIZE GUIDE Wave Plate Caddy Insert MTO 7x11 SNG DP Tray (98-17110) Wave Calcaneal Fracture Plating System Sterilization DJO Surgical Depth Gage Encompass Hip System TIBIAL TUBURCLE ALIGNMENT BAR STM EXT THUMBSCREW Forceps, Malleollar Affiniti EH2 Instrument Base BOM MTO 7x11 SNG SH Tray (07-0395) LID FOR VOLAR CASE Omnifit Direct Anterior DJO Surgical Patella Inserter STEM IMPACTOR UNIVERSAL HEAD IMPACTOR PROV FEM STEM TRAY ASSY, STAYFUSE Affiniti Humeral Instrument kit DVO Volar Plate Case - Lid EU I-Hip Triathlon DJO Surgical Cut Block PCA MI KNEE RETACTOR 2/4 MM TIB DEPTH RES STYLUS FEM GDE BUSHING Cushing Elevator, Fan Tip Affiniti Glenoid Instrument kit AFFINITI EH2 INSTRUMENT TRAY TRAXIS INSTRUMENTS Reunion DJO Surgical Reamer Guide Pin HD HLDR Orthopedic manual instrument LID FOR STAYFUSE CASE CFP QUICK LAUNCH 2 LOCKING SCREW CADDY Rejuvenate Navigation First Step DJO Surgical Broach Handle REAMER SHAFT TIBIAL BOOM 7 DEGREE SPIKE ARM ROTATING PLATFORM BP TRIA STM EXT ASSY LID FOR NCP CASE WAVE CASE BASE FEM NOTCH CUT BLOCK NK CO AXIAL ALIGNMENT ROD ASS'Y CALCANEAL FRACTURE PLATE QUICK LAUNCH CASE Affiniti Humeral Base Wave Lag Screw Index Caddy General Trauma Instrumentation ADJ ALIGN BLOCK DJO Surgical Elevator 11-18007-000-00 SecufFit 11-18146-000-00 Biomet Screwdriver 11-18142-900-00 Encompass Plasma Spared, Press-fit Hip System ESCALATE COLLAPSER BLOCK C-Taper Head 11-18008-000-00 Calibrated Introducer Tri-plus DCM Liner Direct Anterior Instruments Pagoda Pedicle Screw System COSMOLOCK Revision Cutting Block Direct Anterior Instrument Triathlon Trial Component N-K II Proximal Tibia Ali Drill Bit, 8MM ESCALATE PLATE HOLDER Verte-stack Spinal System ESCALATE LAMINA ELEVATOR V40 Femoral Head S-ROM Universal Impactor Stem Tri-plus Acetabular Shell DJO Surgical Rasp INTESS CERVICAL ESCALATE EXPANDER Meta-Tan ESCALATE AWL ESCALATE SCREWDRIVER Hudson BHR TOTAL JOINT ORTHOPEDICS, INC. AGC Tibial Resection Broach Blank BIOMET END CAP REMOVAL TOOL Profemur AM Rasp Klassic Mcelroy Retaining Rod DJO Surgical Head Gage Plate Fortitude Tapered Tial Locking Screw QUANTUM SPINAL FIXATION SYSTEM CONTACT ALP ANTERIOR LUMBAR PLATE SYSTEM, C-PLUS PEED VBR/IBF SYSTEM INSTRUMENT LITE PLATE SYSTEM MIS QUAD-SPARING TOTAL KNEE PROCEDURE General Instrumentation Balanced Knee System Herbert/Whipple Bone Screw System STEINMAN PIN INSERTER RP TIBIAL TRAY IMPACTOR Integra Surgical Instrument POLY EXTRACTOR ITST Intertrochangeric/Subtrochanteric Fixation Biomet Orthopedic ALIGNMENT TOWER STANDARD PUNCH GUIDE MODULAR STEM ADAPTER FEMORAL IMPACTOR REPLACEMENT NYLON POWER PIN DRIVER ALTERNATE BEARING FEMORAL HEAD TRIAL MBT SPACER BLOCK TIBIAL TRAY TRIAL ARTIC/EZE TR BALL GRVD FBT SPACER BLOCK PROXIMA CANAL FINDER DEPUY RECLAIM DISASSEMBLY TORQUE HANDLE Periarticular Plate Distal Lateral Femoral Plate Jig Right AML BROACH HANDLE OFFSET TIB NCEM PNCH GDE SZ 1.53 Temporary Fixation Pin ENDURANCE BROACH HANDLE 4TH DILATOR SPOTLIGHT FEM REV A/P CUTTING GDE BUSHING-OFFSET TIBIAL TRAY HANDLE CRUCIATE SUBSTITUTING BOX TRIAL 1.6mm Adjustable Parallel Wire Guide Neuflex MCP Broach SZ 10 Prox SP2 MI FEM NOTCH GD DEPUY RECLAIM DISTAL REAMER EXTENSION LCS PW IM PLATE 0 DEG TRAY TRIAL ALIGNMENT HANDLE Corail AMT Modular Bone Impactor PIN PULLER CORAIL2 STRAIGHT BROACH HANDLE MBT TRAY TRIAL Corail AMT Trochometer CEMENTED MODULAR PUNCH GUIDE TC3 BOX TRIAL MBT KEEL PUNCH CEMENTED RECLAIM DISASMBLY THREADED CAP Tibial Insert Trial Remover MBT KEEL PUNCH NONCEMENTED DEPUY RECLAIM DISASSEMBLY TOOL ASSEMBLY FEM REV A/P CUTTING GDE BUSHING POLYETHYLENE TIBIAL CONDYLE IMPACTOR MBT KEEL PUNCH IMPACT DEPUY RECLAIM DISASSEMBLY HANDLE NON-CEMENTED MODULAR PUNCH GUIDE ARH Slide-Loc Stem Clamp 1.25mm Cleaning Stylet Pointed Forceps w/ Rachet, Narrow Long 3.5mm Cannulated Hex Driver, QC 4.5/3.2mm Double Drill Sleeve Ring Curette Cement Restrictor Trial 1.35mm Cleaning Brush MBT Punch Bullet (Non-Ribbed) Sizes 1 thru 7 T15 Stick Fit Toggling Hexalobe Driver LCS PW IM Plate 6 Deg LT Tibial Sizing Template Handle Assembly CSR Shoulder System Reduction Forceps w/ Rachet, Long 3/3.5/4mm Holding Sleeve Optetrak Broach Corail AMT 13 Obsolete - SROM Oblong Cup Attune MBT DAA BENT HOHMAN RETRACTORS,
LEFT FEMORAL NECK ELEVATOR Hohmann Retractor, Deep, Left Pointed Forceps w/ Ratchet, Wide Long DAA BENT HOHMAN RETRACTORS,
RIGHT Sigma Octane Fragment Plate Cutter Compress Instruments Pinnacle Cup System Acetabular Retractor, Deep, Left 3.5mm Solid Hex Driver, QC Acetabular Retractor, Deep, Right 2.7/1.3mm Double Drill Sleeve ENCORE REVERSE HUMERAL PLANAR, SMALL Octane Cup Curette 3/3.5mm Screw Sizer T-Handle Reamer Duraloc Cup System LCS MRI Crochet Hook Custom Quick Launch Tray Chamfer Tool Tray Gage Mueller Cement Removal Instrument Case General Screw Removal ElbowLoc Bottom Stabilizer General Hip Manual Knee DJO Surgical Caliper Probe Worland Tibial Impaction Discectomy Instruments Patella Preparation Pedicle Finder Handle Lobster Claw Cutting Edge Duracon Extended Tibial Entry Sheath Handle CONSENSUS ORTHOPEDICS, INC. T-Handle, Zimmer, Assy Bottom Ratchet Partnership HTO DEPTH GAUGE ASSY Cannulated Hex Driver VOLAR CASE SCREW CADDY NEXFIX NCP SYSTEM, MEASURING GUIDE BIOMET ORTHOPEDIC MANUAL SURGICAL INSTRUMENT AFFINITI EH2 44MM TUBEROSITY REAMER NATURAL IMPLANT HOLDER C-Assist SuperCable Iso-Elastic Cerclage (Tray Only) AFFINITI GLENOID CASE ASSEMBLY DVO MLFX INTRAFOCAL PIN PLATE SYSTEM STABILIS STERILIZATION TRAY, ASSEMBLY Top Ratchet Reference Frame Right Manual Hip Bone Tap, Cortical Dall Miles Introducer DJO Surgical RSP Impaction Fixture TIBIAL BROACH IMPACTOR T-HANDLE ZIMMER ATTACHMENT TIB RMRS, ROTATING PLATFO N-K II PROXIMAL TIBIA ALI PreCept & Armada DJO Surgical Retractor Wave Non Locking Fully Threaded Screw Index Caddy Accolade ArthroCare, Parasorb, Tray VOLAR CASE LID Affiniti Humeral Bottom Tray Ascend Modular Core Instrument Case DJO Surgical Drill Guide Handle Orthopedic manual surgical instrument DJO Surgical RSP Monoblock Impaction Fixture AFFINITI EH2 48MM TUBEROSITY REAMER ART SURF INSERT INST AFP QUICK LAUNCH CASE ASSEMBLY LATITUDE EV INSTRUMENT CASE LID NATURAL IMPLANT HOLDER RO GLENOID PLANER Knee Instruments/Other Hand Held Fracture Jig Case AFP QL Screw Caddy AFFINITI EH2 56MM TUBEROSITY REAMER Trident NATURAL IMPLANT ROD THREA BOX,FULL OVERLAP, WHITE, 103/4X31/2X215/8 General Knee Instrumentation TROCHANTER BURR 13MM APR ZUK DISTAL TELESCOPING ROD 60 NK PAT OSTY GD ASSY Champion Shoulder Instrumentation LATITUDE QLS REVISION CASE - UNIVERSAL IFPP Screw Caddy LATITUDE QLS PRIMARY CASE - ULNAR Hex Driver Restoration Modular Other Hip HTO OST GUIDE ASSY SPIKE ARM TELESCOPING ROD General Hip Instrumentation DISTAL TELESCOPING ROD DJO Surgical Femoral Head Corkscrew LATITUDE QLS REVISION CASE Affiniti Humeral Lid Reference Frame Spacer Hip Revision DISTAL FEM RES HOLDING PEG HEAD-NECK INSERTER HANDLE Reference Frame Left IFPP Base HEAD INSERTER SLOTTED VARUS/VALGUS CUT VOLAR PEG-LAG SCREW CADDIE Aequalis Humeral Nail kitted Case DJO Surgical Pelvis Elevator IM TIBIAL RESECTOR 7 DEGREE Affiniti Humeral Middle Tray VOLAR CASE OUTER Wave Case Lid Scorpio MRH TAPER SEATING TOOL FOOT HOLDING FIXTURE Aluminum Tray with Brackets Meniscal Transplantation Slot Instruments TUBERCLE ARM Aequalis Humeral Nail Case Screw Caddie Ascend Modular Anatomic Instrument Case DJO Surgical RSP Trial Adaptor FORTITUDE INSTRUMENTS Summit Std Imp-Inserter Solar SPOUT MILL CUTTER MOD TAPER SEATING CONNECTOR Affiniti Humeral Top Tray LATITUDE EV INSTRUMENT CASE 2 MIK SMALL HOHMANN RETRACTOR SCP Graduated Guided Pin Manual General ZIMMER TO HUDSON ADAPTER Manual Revision TRAY ASSY, COMPRESSION PIN HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2020-02-05
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2020-02-05
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2005-03-14
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2013-04-16

Official Correspondent

No official correspondent registered.

US Agent Details

Michael Parrish Email: mike.parrish@tecomet.com Phone: (574) 2678700

Related Public Records

Same Entity

Tecomet

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1225675	Tecomet Inc.	Wilmington, MA, US
3003791208	SYMMETRY MEDICAL MANUFACTURING INC.	Lansing, MI, US
3005226664	Tecomet, Inc.	Wilmington, MA, US
1226425	TECOMET	Woburn, MA, US
1221053	SYMMETRY MEDICAL, INC. - MANCHESTER	MANCHESTER, NH, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K901338	Kirschner Medical Corp.	KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM	1990-05-22
K030577	Stelkast Company	PROVEN MODULAR TIBIAL TRAY	2003-03-25
K153310	Total Joint Orthopedics, Inc.	Klassic Knee System	2015-12-17
K102380	Wrightmedicaltechnologyinc	EVOLUTION MP TOTAL KNEE SYSTEM	2011-01-07
K122985	Aesculap Implant System, Inc.	COLUMBUS REVISION KNEE SYSTEM	2012-10-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2019	Smith & Nephew, Inc.	2	Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229
Z-0002-2019	Smith & Nephew, Inc.	2	JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 74021131, 74021132, 74021133, 74021134, 74021135, 74021136, 74021137, 74021138, 74021139, 74021140, 74021141, 74021142, 74021143, 74021144, 74021145, 74021146, 74021147, 74021148, 74021149
Z-0003-2017	Zimmer Biomet, Inc.	2	Vanguard 360 Revision Knee System Knee prostheses
Z-0003-2019	Smith & Nephew, Inc.	2	JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 74023125, 74023126, 74023127, 74023128, 74023131, 74023132, 74023133, 74023134, 74023135, 74023136, 74023137, 74023138, 74023141, 74023142, 74023143, 74023144, 74023145, 74023146, 74023147, 74023148, 74023211, 74023212, 74023213, 74023214, 74023215, 74023216, 74023217, 74023218, 74023221, 74023222, 74023223, 74023224, 74023225, 74023226, 74023227, 74023228, 74023231, 74023232, 74023233, 74023234, 74023235, 74023236, 74023237, 74023238, 74023241, 74023242, 74023243, 74023244, 74023245, 74023246, 74023247, 74023248, 74023251, 74023252, 74023253, 74023254, 74023255, 74023256, 74023257, 74023258, 74023261, 74023262, 74023263, 74023264, 74023265, 74023266, 74023267, 74023268, 74023271, 74023272, 74023273, 74023274, 74023275, 74023276, 74023277, 74023278, 74023281, 74023282, 74023283, 74023284, 74023285, 74023286, 74023287, 74023288, 74023311, 74023312, 74023313, 74023314, 74023315, 74023316, 74023317, 74023318, 74023321, 74023322, 74023323, 74023324, 74023325, 74023326, 74023327, 74023328, 74023331, 74023332, 74023333, 74023334, 74023335, 74023336, 74023337, 74023338, 74023341, 74023342, 74023343, 74023344, 74023345, 74023346, 74023347, 74023348, 74023411, 74023412, 74023413, 74023414, 74023415, 74023416, 74023417, 74023418, 74023421, 74023422, 74023423, 74023424, 74023425, 74023426, 74023427, 74023428, 74023431, 74023432, 74023433, 74023434, 74023435, 74023436, 74023437, 74023438, 74023441, 74023442, 74023443, 74023444, 74023445, 74023446, 74023447, 74023448, 74023451, 74023452, 74023453, 74023454, 74023455, 74023456, 74023457, 74023458, 74023461, 74023462, 74023463, 74023464, 74023465, 74023466, 74023467, 74023468, 74023471, 74023472, 74023473, 74023474, 74023475, 74023476, 74023477, 74023478, 74023481, 74023482, 74023483, 74023484, 74023485, 74023486, 74023487, 74023488, 74023648, 74203326
Z-0013-06	Plus Orthopedics USA	2	TC-PLUS Tibial Insert Ultra-Congruent Size 10 ; 9 mm, Model 25456

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004196040. Last updated year: 2026. Please use registration number 3004196040 when referencing this establishment in official correspondence.