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)
Top companies in HSB
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer Biomet, Inc. | 0 | 295 |
| DePuy Orthopaedics, Inc. | 9 | 116 |
| Zimmer GmbH | 23 | 50 |
| Stryker | 12 | 37 |
| Howmedica Osteonics | 39 | 0 |
| OrthoPediatrics Corp. | 7 | 31 |
| Ebi, L.P. | 1 | 31 |
| Advanced Orthopaedic Solutions, Inc. | 15 | 12 |
| NuVasive Specialized Orthopedics | 18 | 9 |
| Synthes (Usa) | 23 | 4 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 16, 2026 | Smith & Nephew, Inc. TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816 Open, Classified |
HSB | K210980 |
| Dec 22, 2025 | Zimmer, 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 |
HSB | K241651 |
| Dec 22, 2025 | Zimmer, 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 |
HSB | K241651 |
| Dec 22, 2025 | Zimmer, 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 |
HSB | K241651 |
| Dec 22, 2025 | Zimmer, 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 |
HSB | K241651 |
| Dec 22, 2025 | Zimmer, 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 |
HSB | K241651 |
| Dec 22, 2025 | Zimmer, 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 |
HSB | K241651 |
| Dec 22, 2025 | Zimmer, 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 |
HSB | K241651 |
| Dec 22, 2025 | Zimmer, 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 |
HSB | K241651 |
| Dec 22, 2025 | Zimmer, 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 |
HSB | K241651 |
| Dec 22, 2025 | Zimmer, 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 |
HSB | K241651 |
| Dec 22, 2025 | Zimmer, 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 |
HSB | K241651 |
| Dec 22, 2025 | Zimmer, 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 |
HSB | K241651 |
| Dec 22, 2025 | Zimmer, 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 |
HSB | K241651 |
| Dec 22, 2025 | Zimmer, 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 |
HSB | K241651 |
| Dec 22, 2025 | Zimmer, 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 |
HSB | K241651 |
| Dec 22, 2025 | Zimmer, 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 |
HSB | K241651 |
| Dec 22, 2025 | Zimmer, 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 |
HSB | K241651 |
| Dec 2, 2025 | Paragon 28, Inc. Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S Open, Classified |
HSB | K234128 |
| Jun 13, 2025 | Orthofix Srl REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile Open, Classified |
HSB | K233867 |
| Jun 10, 2025 | Stryker GmbH Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S. Open, Classified |
HSB | K101438 |
| Jun 10, 2025 | Stryker GmbH Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S. Open, Classified |
HSB | K101438 |
| Jun 6, 2025 | Stryker GmbH Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S. Open, Classified |
HSB | K213328 |
| May 19, 2025 | Smith & Nephew, Inc. META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690 Open, Classified |
HSB | K092748 K210980 |
| Nov 21, 2024 | NuVasive 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 |
HSB | K232267 |
| Mar 5, 2024 | Paragon 28, Inc. Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R Open, Classified |
HSB | K210869 |
| Mar 5, 2024 | Paragon 28, Inc. Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L Open, Classified |
HSB | K210869 |
| Mar 5, 2024 | Paragon 28, Inc. Phantom TTC Nail, 10.0 X 200mm, Right Open, Classified |
HSB | K210869 |
| Mar 1, 2024 | Synthes (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 |
HSB | K131548 K160167 |
| Mar 1, 2024 | Synthes (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 |
HSB | K131548 K160167 |
| Mar 1, 2024 | Synthes (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 |
HSB | K051678 |
| Oct 6, 2023 | Flower 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 |
HSB | K202858 |
| Aug 22, 2023 | Smith & Nephew, Inc. TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail Open, Classified |
HSB | K040462 K210980 |
| Aug 22, 2023 | Smith & Nephew, Inc. TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail Open, Classified |
HSB | K040462 K210980 |
| Mar 10, 2023 | Synthes (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 |
HSB | K131548 |
| Mar 10, 2023 | Synthes (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 |
HSB | K131548 |
| Mar 10, 2023 | Synthes (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 |
HSB | K131548 |
| Jan 27, 2023 | Biomet, 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 |
HSB | K042409 |
| Dec 1, 2021 | NuVasive 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 |
HSB | K101997 K113695 +2 |
| Nov 2, 2021 | Flower 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 |
HSB | K202858 |
| May 27, 2021 | Stryker GmbH Nail Insertion Sleeve, elastic T2 Tibia SPI 8-11 (SPI Elast. Sleeve 8-11), Catalog Number 18061406S Open, Classified |
HSB | K131365 |
| May 27, 2021 | Stryker GmbH Nail Insertion Sleeve, elastic T2 Tibia SPI 8-13 (SPI Elast. Sleeve 8-13), Catalog Number 18061407S Open, Classified |
HSB | K131365 |
| May 7, 2021 | Zimmer 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 |
HSB | K091566 |
| May 7, 2021 | Zimmer 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 |
HSB | K091566 |
| Apr 5, 2021 | Nuvasive 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 |
HSB | K141739 |
| Apr 5, 2021 | Nuvasive 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 |
HSB | K113695 |
| Apr 5, 2021 | Nuvasive 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 |
HSB | K101997 K151131 |
| Mar 30, 2021 | Nuvasive 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 |
HSB | K192181 |
| Mar 30, 2021 | Nuvasive 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 |
HSB | K182170 K201567 |
| Mar 30, 2021 | Nuvasive 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 |
HSB | K180503 |
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