Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007539489

FEI Number

3007539489

Entity Name

Paragon Medical Device (Changzhou) Co., Ltd.

City/State/Country

Changzhou Jiangsu, CN

Establishment Address

3A GDH Industrial Park, No. 16 Chuangye Road, Changzhou Jiangsu 213033, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Paragon Medical (Owner Number: 9011072)

Owner / Operator Contact Address

8 Matchett Dr., --, Pierceton, IN 46562, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Drill Sleeve Insert K-Wire Sleeve Insert Orthopedic Manual Surgical Instrument LITe Funnel Bone Tap Freehand Drill IMN Instruments ø4.2x185mm Locking Drill IMN Instruments ø4.2x360mm Trocar SPS-MonoAxial Locking Set 5mm Inserter sleeve Freehand Drill IMN Instruments ø3.5x130mm Drill Sleeve D4.3 "Insertion Sleeve for ø3.2mm Guide Wires" Depth Gauge 0-120mm Insert ø3.2 compression Guide Wire D3xL300 Trocar SPS-MonoAxial Locking Set 4mm Freehand Drill IMN Instruments ø3.5x185mm Zimmer Biomet Drill Guide ø6.55 Drilling Guide ø3.2/4.5 Locking Drill IMN Instruments ø3.5x360mm Depth Gauge 0-70mm for Screws: ø2.7/3.5/4mm Freehand Drill IMN Instruments ø4.2x130mm Insert ø2.5 compression Tissue prot. sleeve ø6.5/4.5 Threaded Guide Wire D3.2xL300 (Sterile) Screw Insertion Sleeve ø9mm Lag Screw Tap Sleeve Drilling Guide ø2.5/3.5 Parallel Drill Guide Insert ø2.5 neutral Drill Sleeve Handle Direct Measuring Gauge Depth Gauge 0-150mm for Screws: ø4.5/6.5mm Drill Guide Supracondylar Lag Screw Depth Gauge Drill Sleeve D3.1 Depth Gauge 0-110mm For Screws ø2.7/3.5/4 Depth Gauge 0-150mm for Screws: ø2.7/3.5/4mm Insert ø2.5 support Drilling Guide ø2/2.7 Drill Gauge (Percutaneous) Guide Wire D3.2xL300 Threaded Guide Wire D3.2xL300 Guide Wire with Ruler Tube Insert ø3.2 neutral Guide Wire D3.2xL300 (Sterile) Distractor Twist Drill Centerpiece Plate Fixation System C-STEM AMT SZ 3A NK SEGMENT IMN Instruments C-STEM AMT STD NECK SEGMENT- SZ0/1 INSERTION SHIM - HANDLE Guide Wire C-STEM AMT SZ 2A NK SEGMENT C-STEM AMT HO NECK SEGMENT- SZ4/5 C-STEM AMT HO NECK SEGMENT- SZ 0/1 C-STEM AMT HO NECK SEGMENT- SZ2/3 C-STEM AMT STD NECK SEGMENT- SZ2/3 C-STEM AMT STD NECK SEGMENT- SZ6/7 Tornier HRS Max Driver Intermediate Zimmer Biomet Tap, Locking, AO Zimmer Biomet Fluted Pin Various Drills for Foot Surgery (Twist Drill, Over-Drill, Drill Bit) Universal Pin Persona® The Personalized Knee System PERSONA NATURAL TIBIA BASEPLATES KEEL TIB PUNCH GUIDE SZ1.5-4 Tornier HRS Max Persona Revision Knee System Mallet Navlock Black and Blue Trackers AMBI Zimmer Biomet CHIMAERA INSTRUMENT TRAY, EMPTY CHIMAERA INSTRUMENT TRAY EXTRA EMPTY EXTRACTION INSTRUMENT TRAY EMPTY INITIA INTERMEDIATE SIZE BROACH CASE LEGION Screwdriver Zimmer Persona Personalized Knee System PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER Persona® The Personalized Knee System Persona Revision Knee System STERILIZATION BOX EMPTY PERI-LOC IMN Instruments Drill Bit, AO RG 9.5 BALLAST TAP LONG RG BALLAST TAP LONG RG 10.5 BALLAST TAP LONG RG 11.5 BALLAST TAP LONG RG BALLAST DRILL 4.2 x 70 LONG RG AWL-TIP TAP LONG RG SOLERA AWL-TIP TAP SHORT RG DRILL 3 x 30 SHORT RG DRILL 3 x 30 LONG RG 8.5 BALLAST TAP LONG Zimmer Persona Personalized Knee System Persona® The Personalized Knee System Persona® The Personalized Knee System PERSONA NATURAL TIBIA BASEPLATES LEGION Driver 9735253 T-Handle 5mm Hex

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2007-12-28
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2013-01-30
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2017-05-31
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-03-26
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2011-03-16
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2013-01-20
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2013-01-30
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2013-01-30
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2017-06-05
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2017-06-05
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2017-06-05
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2017-07-28
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2022-03-09
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-04-16
HWT	Template	Orthopedic	Class 1	888.4800	2013-01-20
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-01-18
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2023-11-10
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2023-11-10
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2023-11-10
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2017-06-05
HXC	Wrench	Orthopedic	Class 1	888.4540	2016-12-13
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2017-07-12
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2019-07-10
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-10-30
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-01-17
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2018-11-09
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2013-01-30
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2021-12-16
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2017-07-28
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2013-01-20
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2017-07-28
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2019-07-17
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2015-03-06
MBV	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2015-03-06
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2018-11-06
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2018-11-06
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2018-11-06
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2017-11-22
NJL	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing	Unknown	Class 3	N/A	2016-07-18
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2015-01-27
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2018-11-27
HXG	Tamp	Orthopedic	Class 1	888.4540	2013-01-30
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2017-02-21
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2020-12-16
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2020-12-16
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2020-12-16
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2008-10-14
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-06-11
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2025-04-16
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2013-01-18
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2013-01-18
KRQ	Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3550	2013-01-18
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3540	2013-01-18
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-01-18
NPJ	Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-01-18
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3530	2013-01-18
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2013-01-18
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2018-11-21
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2018-11-21

Official Correspondent

Stephane Langlois

US Agent Details

Stephane Langlois Business: Paragon Medical Email: stephane.langlois@ametek.com Phone: (435) 5355456

Related Public Records

Same Entity

Paragon Medical

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3009141957	AMETEK Poland sp. z o.o.	Siechnice Dolnoslaskie, PL
1834331	PARAGON MEDICAL, INC.	PIERCETON, IN, US
1835831	Paragon Medical Inc.	Castleton, IN, US
1000517406	Paragon Medical Inc.	Smithfield, UT, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K260601	Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	2026-03-26
K033476	Howmedica Osteonics Corp.	MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM	2004-01-20
K984202	Howmedica, Inc.	HOWMEDICA HUMERAL INTERCALARY SYSTEM	1999-02-05
K904879	Endotec, Inc.	BEUCHEL-PAPPAS GLENOID COMPONENT	1991-01-28
K010427	Walter Lorenz Surgical, Inc.	LORENZ FIDUCAIL SCREW	2001-03-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007539489. Last updated year: 2026. Please use registration number 3007539489 when referencing this establishment in official correspondence.