Panels › Orthopedic › Product code HSB · Class 2
Rod, Fixation, Intramedullary And Accessories
Regulation 888.3020
20510(k)s in 12 months (532 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) |
|---|---|---|---|
| Dec 17, 2020 | Biomet, Inc. PHOENIX, Interlocking screw for IM nail, Item numbers 14-405040, 14-405042, 14-405044, 14-405070 - Product Usage: Fracture fixation of small bones, small bone fragements and long bones. Terminated |
HSB | K063570 |
| Sep 18, 2020 | Merete Medical GmbH OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus) Terminated |
HSB | K181026 |
| Sep 18, 2020 | Merete Medical GmbH OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (tibia) Terminated |
HSB | K181026 |
| Sep 18, 2020 | Merete Medical GmbH OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (femur) Terminated |
HSB | K181026 |
| Sep 18, 2020 | Merete Medical GmbH OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails Terminated |
HSB | K101939 |
| Jul 24, 2020 | Nuvasive Specialized Orthopedics Inc NUVASIVE SPECIALIZED ORTHOPEDICS, INC. Precice Bone Transport Antegrade Femur Trochanter 10 Degree Bend
Component of the orthopedic Precice Bone Transport System of intramedullary nail, locking screw Open, Classified |
HSB | K193016 K201567 |
| Jun 16, 2020 | Stryker GmbH Stryker End Cap, Std, Ti Gamma3
Catalog Number: 30051100S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones. Terminated |
HSB | K032244 |
| Jun 16, 2020 | Stryker GmbH Stryker Locking Screw, Fully Threaded T2 Tibia 5x50 mm
Catalog Number: 18965050S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilizati Terminated |
HSB | K032244 |
| Jun 16, 2020 | Stryker GmbH Stryker Locking Screw, Fully Threaded T2 Tibia 5x45 mm
Catalog Number: 18965045S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilizati Terminated |
HSB | K032244 |
| Jun 16, 2020 | Stryker GmbH Stryker Locking Screw, Fully Threaded T2 Tibia 5x40 mm
Catalog Number: 18965040S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilizati Terminated |
HSB | K032244 |
| Jun 16, 2020 | Stryker GmbH Stryker Locking Screw, Fully Threaded T2 Tibia 5x37,5 mm Catalog Number: 18965037S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabiliz Terminated |
HSB | K003018 |
| Jun 16, 2020 | Stryker GmbH Stryker Locking Screw, Fully Threaded T2 Tibia 5x35 mm
Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilizati Terminated |
HSB | K032244 |
| Jun 16, 2020 | Stryker GmbH Stryker Locking Screw, Fully Threaded T2 Tibia 5x30 mm
Catalog Number: 18965030S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabiliza Terminated |
HSB | K032244 |
| Jun 16, 2020 | Stryker GmbH Stryker Locking Screw, Fully Threaded T2 Humerus 4x32 mm
Catalog Number: 18964032S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabiliza Terminated |
HSB | K003018 |
| Jun 16, 2020 | Stryker GmbH Stryker Locking Screw, Partially Threaded T2 Tibia 5x55 mm
Catalog Number: 18915055S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabili Terminated |
HSB | K032244 |
| Jun 16, 2020 | Stryker GmbH Stryker End Cap T2 Humerus 6mm, 15mm height
Catalog Number: 18300015S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bon Terminated |
HSB | K011529 |
| Jun 16, 2020 | Stryker GmbH Stryker 1 End Cap T2 Humerus 6mm, 5mm height
Catalog Number: 18300005S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bo Terminated |
HSB | K011529 |
| Jun 16, 2020 | Stryker GmbH Stryker End Cap, Standard T2 Humerus 6 mm
Catalog Number: 18300003S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones Terminated |
HSB | K011529 |
| Jun 16, 2020 | Stryker GmbH Stryker End Cap T2 Tibia +10 mm
Catalog Number: 18220010S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones. Terminated |
HSB | K003018 |
| Jun 16, 2020 | Stryker GmbH Stryker Compression Screw, Advanced T2 Tibia
Catalog Number: 18220001S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bon Terminated |
HSB | K003018 |
| Jun 16, 2020 | Stryker GmbH Stryker Locking Screw, Fully Threaded S2 05x35 mm
Catalog Number: 17965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of Terminated |
HSB | K032579 |
| Oct 10, 2019 | Zimmer Biomet, Inc. Cephalomedullary Nail (CMN), Various sizes, Item Nos. 47249318009
47249318010
47249318011
47249318013
47249318014
47249318109
47249318110
47249318111
47249318113
47249318114
47249318209
47249318210
47 Terminated |
HSB | K091566 |
| Oct 10, 2019 | Zimmer Biomet, Inc. FEMOROTIBIAL/FEMORAL NAIL, various sizes. Item Nos. 32855331111
32855331113
32855331115
32855331161
32855331163
32855331165 Terminated |
HSB | K853250 |
| Oct 10, 2019 | Zimmer Biomet, Inc. Various fixation systems and accessories, Item Nos. 00224000916
00224000918
00224000920
00224000922
00224000924
00224000926
00224000928
00224000930
00224000932
00224000934
00224000936
00224000938
0022 Terminated |
HSB | K142281 |
| Aug 19, 2019 | OrthoPediatrics Corp Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation r Terminated |
HSB | K172583 |
| Aug 19, 2019 | OrthoPediatrics Corp Model No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (pr Terminated |
HSB | K172583 |
| Aug 19, 2019 | OrthoPediatrics Corp OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an orthopedic implant system
(bolt is used to attach the targeting arm to the int Terminated |
HSB | K172583 |
| May 29, 2019 | Pega Medical Inc. SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System Terminated |
HSB | K143355 |
| Oct 2, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail 130 Deg 12x165mm, Item Number 816812165
The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabi Terminated |
HSB | K100238 |
| Oct 2, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail 130 Deg 10x165mm, Item Number 816810165
The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabi Terminated |
HSB | K100238 |
| Oct 2, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail 125 Deg 12x165mm, Item Number 816712165
The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabi Terminated |
HSB | K100238 |
| Oct 2, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail 125 Deg 10x165mm, Item Number 816710165
The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabi Terminated |
HSB | K100238 |
| Oct 2, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 Deg 9x165mm, Item Number 816709165
The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to s Terminated |
HSB | K100238 |
| Oct 2, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 130 Deg 11x300mm, Item Number 814611300
The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to Terminated |
HSB | K100238 |
| Oct 2, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 Deg 11x300mm, Item Number 814411300
The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to Terminated |
HSB | K100238 |
| Oct 2, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left Deg 9x300mm, Item Number 814609300
The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabi Terminated |
HSB | K100238 |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 130 15 mm x 360 mm, Item Number: 814615360 Terminated |
HSB | K100238 |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 130 13 mm x 460 mm, Item Number: 814613460 Terminated |
HSB | K100238 |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 130 13 mm x 440 mm, Item Number: 814613440 Terminated |
HSB | K100238 |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 130 13 mm x 420 mm, Item Number: 814613420 Terminated |
HSB | K100238 |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 130 13 mm x 400 mm, Item Number: 814613400 Terminated |
HSB | K100238 |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 130 13 mm x 380 mm, Item Number: 814613380 Terminated |
HSB | K100238 |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 130 13 mm x 360 mm, Item Number: 814613360 Terminated |
HSB | K100238 |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 130 13 mm x 340 mm, Item Number: 814613340 Terminated |
HSB | K100238 |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 130 13 mm x 320 mm, Item Number: 814613320 Terminated |
HSB | K100238 |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 130 13 mm x 300 mm, Item Number: 814613300 Terminated |
HSB | K100238 |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 130 13 mm x 280 mm, Item Number: 814613280 Terminated |
HSB | K100238 |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 130 13 mm x 260 mm, Item Number: 814613260 Terminated |
HSB | K100238 |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 130 11 mm x 460 mm, Item Number: 814611460 Terminated |
HSB | K100238 |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 130 11 mm x 440 mm, Item Number: 814611440 Terminated |
HSB | K100238 |
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