Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026368553

FEI Number

3026368553

Entity Name

INTEGRITY ORTHOPAEDICS, INC.

City/State/Country

Maple Plain, MN, US

Establishment Address

5565 Pioneer Creek Drive, Maple Plain, MN 55359, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Smith & Nephew, Inc. (Owner Number: 1020279)

Owner / Operator Contact Address

2875 Railroad Street, Pittsburgh, PA 15222, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K222589

PMA Number

N/A

All Registered Proprietary Names

Closed Tendon Harvester ACL Closed Curette Elevator Rasp Bone Tap Point to Point, ACL Arm Swordfish Meniscal Rasp N8TIVE ACL Disposables Kit Multi-Sizing Block ACL Bullet Hammerhead Rotary Punch Meniscal Lift Piranha Junior ACL Disposables Guidewire Kit Passing Pin Puller Titan Removal Tool Capture Sleeve Graft, Base Lock Blunt Nose Junior Cannulated Switching Stick Graft, Suture Clamp N8TIVE ACL Tunnel Rasp Clearcut Suture Cutter Hammerhead Rotary Scissor ACL Disposables Kit Suture Clamp Tension meter N8TIVE ACL Tibial Dilator Suture Hook Bilok ST Graft Expander N8TIVE ACL Curette N8TIVE ACL Femoral Drill Guide Trocar Tunnel Expander Manta Piranha Arthroscopic Rongeur N8TIVE ACL Tibial Sheath Inserter Universal Rachet Handle ACL Open Curette N8TIVE ACL Tibial Button Impactor Beluga Retro Titan Bone Punch Crochet Hook N8TIVE ACL Depth Gage Jaws Retro Toothed Grasper N8TIVE ACL Graft Sizing Block Femoral Aimer MegaMouth Grasper Jaws Retro Junior Grasper Guidewire Aimer Chondral Pick Wissinger Rod Jaws Great White Grasper A-Tech Femoral Locator Handle N8TIVE ACL Tendon Harvester Radial Clamp Tunnel Notcher Tibial Tunnel Plug Toothless Shark Atraumatic Grasper Graft, Tissue Clamp Transverse Arm Ankle Distractor Small Joint Probe Point to Elbow, ACL Arm Transverse Bullet Marlin Long Probe ACL Tunnel Rasp Single Hole Knot Pusher Graft Board Hook A-Tech Controlled Flexion Guidewire Metal Screw Driver Shaft Probe Femoral Locator Lobster Claw Suture Retriever Cuff Elevator Removal Tool Driver; MTO DRIVER 3.5MM 1.5MM CANN W/HUD ADAP; MTO DRIVER BIORCI W/HUDSON ADAPTOR Graft Bar Holder Jaws Tigar Shark Grasper Cannula Driver Ankle Distractor Strap Graft Assist, Board TRIGEN Slap Hammer Tapered Tap Depth Probe Slotted Tendon Harvester REFLECTION EMPERION Adaptor JOURNEY Inserter Tip Rotation Medical Mini-Open Instrument Kit PERI-LOC Rotation Medical Arthroscopic Instrument Kit TANDEM Integra Glenoid Holder GENESIS Integra Surgical Instrument - Driver LARGE QWIX QWIX Biosure Guide Wire, 1.2mm x 9 inch, Box of 5, Sterile PANTA 1.5mm Guidewire, 12", 72202189 Cannuflex 9" Blunt Guidewire, 72202807 Integra Surgical Instrument Set Awl straight 3.8mm, 72202986 Accu-Pass Suture Shuttle, Monoflement Size No. 1, Single Pack, Sterile - 72201361 Accu-pass suture shuttle, crescent, 7210427 Wire and pin pac (C) Integra Pin Puller Accu-pass suture shuttle, Big Curve Accu-pass suture shuttle left 45 degree, 7210423 Integra Surgical Instrument - Planer Accu-pass suture shuttle 45 degree up, 7210425 LABELS FOR RING MODULE TIBIAXYS Guidewire 1.5mm x 229mm Suretac 6mm Guidewire, 72202809 Accu-pass suture shuttle, straight, 7210426 Twinfix AB 5mm threaded dilator, 72200819 Endobutton Pin Passing 2.4mm Trocar Round Oval Sizing Guide Wire and pin pac (B) Beath pin 2.4mm, 72202815 Biosure 1.2mm x 18", 72201201 Guide wire 2mm, 15", 7207222 Wire and pin pac, 7207738 Guidewire 2.4mm Drill Tip, guide wire, 12", 7207221 Guidewire, Nitinol 1.2mm x 45cm Accu-pass suture shuttle 70 degree, Upbend, 72200419 Passing pin Spade tip 3mm, 72202814 guide wire 2mm Accu-pass suture shuttle right 45 degree Awl tapered 3.8mm Twinfix AB 6.5mm threaded dilator, 72200820 Pliers, Compaction, 9MM PCL Guidewire, 7207284 Arthroscopic needle, 72202825 Awl, tap, driver, dilator MAVERICK MINI Extremities Guide, Universal TWINFIX 3.8 MM STRAIGHT AWL, REUSABLE RCI 7.5 MM TIBIAL STEPPED ROUTER SWISS RAIL CLAMP (LATERAL DSTRCTR SYS) RCI 7.5 MM FEMORAL STEPPED ROUTER 8MM TENDON FORK KNEE HOLDER CANNU-FLEX SCREW GUIDE WIRE, 2 MM X 15 INCH 38 CM, BLUNT TIP, STERILE SMALL INSERTER DSP MTO GUIDEWIRE THREADED 1.5MM X 45CM SUTURE NEEDLE SHUTTLE STERILE 3.5 MM DILATOR GUIDEWIRE CANNFLEX 9 BLUNT TIP EUR/UK LATERAL RAIL CLAMPS 2 0.394 INCH X 0.984 INCH US LATERAL RAIL CLAMP 2 RCI 7 MM FEMORAL STEPPED ROUTER OPEN CURETTE 6MM REVERSE CUT XL 6.5MM DILATOR US SUPINE RAIL CLAMPS 2, 0.375 INCH X 1.125 INCH 1 CM X 2.9 CM WHIPKNOT SOFT TISSUE CINCH 5 SUTURE 2.7 MM DILATOR DENYER RAIL CLAMP (LATERL DSTRCTR SYS) Rotation Tendon Marker AWL STRAIGHT 3.8MM DISPOSABLE TruKor Gauge LOCKING WRENCH 8MM BICEPTOR TAP MANUAL INSTRUMENT TRAY OPEN CURETTE 4.5MM XL Tendon Stabilizing Guide 7MM DILATOR MTO AWL-DILATOR TF ULTRA 4.5 CORTICAL BIORAPTOR KNOTLESS INLINE DRILL GUIDE, SPIKE TIP 5 MM ANTI-IMPINGEMENT DEVICE, USED WITH 9 MM AND 10 MM GRAFTS RCI 8.5 MM FEMORAL STEPPED ROUTER RCI 6.5 MM FEMORAL STEPPED ROUTER BI-GRIP PIN PULLER GUIDE WIRE BEATH PIN 2.4 MM STERILE 7MM TENDON FORK SWISS RAIL CLAMP (SUPINE DSTRCTR SYS) PASSING PIN, 3 MM, SPADE TIP RCI 6.5 MM TIBIAL STEPPED ROUTER WELL LEG HOLDER WITH LEATHER BOOT TWINFIX AB 6.5 THREADED DILATOR TROCAR-TIP PASSING PIN, 2.4 MM X 17 INCH, STERILE STITCHER 9MM TENDON FORK ARTHROSCOPIC NEEDLE STERILE REPLACEMENT LEATHER BOOT 1 TWINFIX AB 5 THREADED DILATOR SCREW GUIDE WIRE, 2 MM X 12 INCH 30CM, BLUNT TIP, STERILE 6 PER PACKAGE STYLET FOR STITCHER 6.5 MM DILATOR RCI 8.5 MM TIBIAL STEPPED ROUTER LOOP TIP GUIDEWIRE MTO TWINFIX ULTRA 5.5 FOR 5.5 CANNULA UNIVERSAL HIP DISTRACTOR WITH LEATHER BOOT ACCU-PASS STR SHTL BIG C STERILE BOX 1 7.5MM DILATOR MTO,SCRW DRVR,LOCKING, 2.5MM HEX, CANN GUIDE WIRE 1.2MM X 9 BOX OF 5 STERILE HAMMER SLAP DILATOR SYSTEM 4.5 MM DILATOR 7MM BICEPTOR TAP GUIDE WIRE PCL 2.4MM X10 KNOT PUSHER XL 12MM DILATOR MTO GUIDE WIRE AC JOINT 2.4 MM PLIERS, COMPACTION, 9mm ACCUPASS STR SHUTL MONOFIL -SEE72201361 1.5 MM TENDON DRILL PIN LARGE TENDON STRIPPER, CLOSED, 7.4 MM I.D. X 13.5 INCH WORKING LENGTH RCI 8 MM TIBIAL STEPPED ROUTER PERINEAL POST ARTHROPIERCE XL STRAIGHT RCI 7 MM TIBIAL STEPPED ROUTER EUR/UK RAIL CLAMP (LATERL DSTRCTR SYS) LARGE INSERTER DSP RCI 8 MM FEMORAL STEPPED ROUTER GUIDE WR 1.2MM X 12 BOX OF 5 STERILE 8.5 MM DILATOR 2.4 MM X 12 INCH DRILL-TIP GUIDE WIRE DIRECTOR PCL ELEVATOR WITH WIRE CATCHER GD WIRE NITINOL 1.2 X 45CM 8MM DILATOR Drill for Q-FIX with Needles 9MM DILATOR ACCU-PASS SUTURE SHUTTLE 70 DEGREE 4 MM ANTI-IMINGEMENT DEVICE, USED WITH 7 MM AND 8 MM GRAFTS 6MM DILATOR TENDON STRIPPER CLOSED TENDON STRIPPER, SLOTTED, 5 MM I.D. X 12 INCH WORKING LENGTH MTO AWL-DIL TF ULTRA 5.5/6.5 CORTICAL 9.5MM DILATOR SUPINE TABLE ATTACHMENT PAD SCREW GUIDE WIRE, 1.5 MM X 12 INCH 30 CM, BLUNT TIP, STERILE BOARD, PATIENT TRANSFER ACCU-PASS SUTURE SHUTTLE, MONOFILAMENT SIZE No.1, SINGLE PACK, STERILE DENYER SUPINE RAIL CLAMPS 2 8.5MM DILATOR 10MM DILATOR GUIDE WIRE 1.2MM X18 BX OF 5 STER. 11MM DILATOR rail clamp, passing pin Tendon Seam Instrument Kit - 8 Anchor Tendon Seam Magazine - 4 Anchor Tendon Seam Magazine - 8 Anchor Tendon Seam Instrument Kit - 4 Anchor

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	2006-10-05
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2026-02-11

Official Correspondent

Lisa Ewing

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Smith & Nephew, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013881076	CARTIHEAL LTD.	Kfar Saba Central, IL
3012130335	Tusker Medical Inc.	Austin, TX, US
3016090213	Blue Belt Technologies, Inc.	Pittsburgh, PA, US
3012358417	Arthrocare Corporation	Coyol Alajuela, CR
1219602	SMITH & NEPHEW INC.	MANSFIELD, MA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K223112	Smith & Nephew, Inc.	MAVERICK Mini External Fixation System	2022-12-08
K072322	Smith & Nephew, Inc.	ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS	2007-09-18
K193295	Parcus Medical, LLC	Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor	2020-01-23
K193606	Conmed Corporation	Y-Knot OneStep Anchor	2020-01-22
K984200	R. Thomas Grotz, M.D., Inc.	STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE	1999-01-21

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-0003-2019	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-0039-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0040-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026368553. Last updated year: 2026. Please use registration number 3026368553 when referencing this establishment in official correspondence.