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Panels › Orthopedic › Product code HSB · Class 2

Rod, Fixation, Intramedullary And Accessories

Regulation 888.3020

19510(k)s in 12 months (531 all time)
19recalls in 12 months (690 all time)
680recalls that name a 510(k)
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Top companies in HSB

DateFirm and productCodeLinked 510(k)
Jun 16, 2026Smith & Nephew, Inc.
TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
Open, Classified
HSBK210980
Dec 22, 2025Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 m
Open, Classified
HSBK241651
Dec 22, 2025Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815809280 Software Version: N/A Product Description: Affixus 9 mm, Length 280 m
Open, Classified
HSBK241651
Dec 22, 2025Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 m
Open, Classified
HSBK241651
Dec 22, 2025Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 m
Open, Classified
HSBK241651
Dec 22, 2025Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 m
Open, Classified
HSBK241651
Dec 22, 2025Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 m
Open, Classified
HSBK241651
Dec 22, 2025Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 m
Open, Classified
HSBK241651
Dec 22, 2025Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 m
Open, Classified
HSBK241651
Dec 22, 2025Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 m
Open, Classified
HSBK241651
Dec 22, 2025Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 m
Open, Classified
HSBK241651
Dec 22, 2025Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 m
Open, Classified
HSBK241651
Dec 22, 2025Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 m
Open, Classified
HSBK241651
Dec 22, 2025Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 m
Open, Classified
HSBK241651
Dec 22, 2025Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 m
Open, Classified
HSBK241651
Dec 22, 2025Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 m
Open, Classified
HSBK241651
Dec 22, 2025Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 m
Open, Classified
HSBK241651
Dec 22, 2025Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 m
Open, Classified
HSBK241651
Dec 2, 2025Paragon 28, Inc.
Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
Open, Classified
HSBK234128
Jun 13, 2025Orthofix Srl
REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
Open, Classified
HSBK233867
Jun 10, 2025Stryker GmbH
Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.
Open, Classified
HSBK101438
Jun 10, 2025Stryker GmbH
Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.
Open, Classified
HSBK101438
Jun 6, 2025Stryker GmbH
Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
Open, Classified
HSBK213328
May 19, 2025Smith & Nephew, Inc.
META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
Open, Classified
HSBK092748
K210980
Nov 21, 2024NuVasive Specialized Orthopedics, Inc.
Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 280mm PM10.0-80B305 PRECICE MA
Open, Classified
HSBK232267
Mar 5, 2024Paragon 28, Inc.
Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R
Open, Classified
HSBK210869
Mar 5, 2024Paragon 28, Inc.
Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L
Open, Classified
HSBK210869
Mar 5, 2024Paragon 28, Inc.
Phantom TTC Nail, 10.0 X 200mm, Right
Open, Classified
HSBK210869
Mar 1, 2024Synthes (USA) Products LLC
TFNA Femoral Nail 11mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.144S
Open, Classified
HSBK131548
K160167
Mar 1, 2024Synthes (USA) Products LLC
TFNA Femoral Nail 9mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.944S
Open, Classified
HSBK131548
K160167
Mar 1, 2024Synthes (USA) Products LLC
13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defec
Open, Classified
HSBK051678
Oct 6, 2023Flower Orthopedics Corporation
Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullary canal to the appropriate depth for nail insertion; Flex-Thread TM 3.2mm is prov
Open, Classified
HSBK202858
Aug 22, 2023Smith & Nephew, Inc.
TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail
Open, Classified
HSBK040462
K210980
Aug 22, 2023Smith & Nephew, Inc.
TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
Open, Classified
HSBK040462
K210980
Mar 10, 2023Synthes (USA) Products LLC
TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures Part Number: 04.037.242S
Open, Classified
HSBK131548
Mar 10, 2023Synthes (USA) Products LLC
TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.212S
Open, Classified
HSBK131548
Mar 10, 2023Synthes (USA) Products LLC
TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.213S
Open, Classified
HSBK131548
Jan 27, 2023Biomet, Inc.
OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee Item
Open, Classified
HSBK042409
Dec 1, 2021NuVasive Specialized Orthopedics, Inc.
NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: Model Number/Item Number/Product Description: CPA1-000 PA0382-001 End Cap CPA2-000 PA1051-000 PACKAGED END CAP, 8.5/ 10.7MM
Open, Classified
HSBK101997
K113695 +2
Nov 2, 2021Flower Orthopedics Corporation
Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue Ratchet Handle in order to facilitate the insertion of the Flex-Thread Nail Syste
Terminated
HSBK202858
May 27, 2021Stryker GmbH
Nail Insertion Sleeve, elastic T2 Tibia SPI 8-11 (SPI Elast. Sleeve 8-11), Catalog Number 18061406S
Open, Classified
HSBK131365
May 27, 2021Stryker GmbH
Nail Insertion Sleeve, elastic T2 Tibia SPI 8-13 (SPI Elast. Sleeve 8-13), Catalog Number 18061407S
Open, Classified
HSBK131365
May 7, 2021Zimmer GmbH
Zimmer Natural Nail- ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 130 CCD Left Ti-6Al-4V Alloy-is intended for temporary fracture fixation and stabilization of the bone Item Number: 47-2493-213-
Terminated
HSBK091566
May 7, 2021Zimmer GmbH
Zimmer Natural Nail -ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 125 CCD Left Ti-6Al-4V Alloy- intended for temporary fracture fixation and stabilization of the bone Item Number: 47-2493-211-11
Terminated
HSBK091566
Apr 5, 2021Nuvasive Specialized Orthopedics Inc
NUVASIVE FREEDOM: End Cap for PRECICE Intramedullary Limb Lengthening System Implant; Packaged End Cap 8.5/10.7mm, +0mm; Packaged End Cap 8.5/10.7mm, +5mm; Packaged End Cap 8.5/10.7mm, +10mm; Package
Open, Classified
HSBK141739
Apr 5, 2021Nuvasive Specialized Orthopedics Inc
NUVASIVE PRECICE UNYTE System (Humerus and Tibia): PRECICE Trauma Nail System/PRECICE Unyte-Humerus Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 165 mm length; Orthopedic trauma in
Open, Classified
HSBK113695
Apr 5, 2021Nuvasive Specialized Orthopedics Inc
NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System End Cap for PRECICE Intramedullary Limb Lengthening System Implant; Packaged End Cap 8.5/10.7mm, +0mm; Packaged End Cap 8.5/
Open, Classified
HSBK101997
K151131
Mar 30, 2021Nuvasive Specialized Orthopedics Inc
PRECICE PLATE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
Open, Classified
HSBK192181
Mar 30, 2021Nuvasive Specialized Orthopedics Inc
Precice Bone Transport - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
Open, Classified
HSBK182170
K201567
Mar 30, 2021Nuvasive Specialized Orthopedics Inc
PRECICE STRYDE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
Open, Classified
HSBK180503

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