Panels › Orthopedic › Product code KTT · Class 2
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Regulation 888.3030
9510(k)s in 12 months (405 all time)
11recalls in 12 months (89 all time)
85recalls that name a 510(k)
Top companies in KTT
| Company | 510(k)s | Recalls |
|---|---|---|
| Ebi, L.P. | 36 | 2 |
| Synthes | 33 | 1 |
| Stryker Corp. | 11 | 15 |
| Orthofix Srl | 11 | 12 |
| Howmedica Corp. | 22 | 0 |
| Howmedica Osteonics Corp. | 19 | 1 |
| Zimmer, Inc. | 10 | 9 |
| Smith & Nephew | 16 | 0 |
| Wrightmedicaltechnologyinc | 11 | 0 |
| Alliance Medical Corp. | 9 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 29, 2026 | Stryker GmbH Stryker Hoffmann II Connecting Rod Micro 3 x 150mm. Catalog Number: 50796150. Open, Classified |
KTT | K033476 |
| Jul 29, 2026 | Stryker GmbH Stryker Hoffmann II Connecting Rod Micro 3 x 120mm. Catalog Number: 50796120. Open, Classified |
KTT | K033476 |
| Jul 29, 2026 | Stryker GmbH Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090. Open, Classified |
KTT | K033476 |
| Jul 29, 2026 | Stryker GmbH Stryker Hoffmann II Connecting Rod Micro 3 x 60mm. Catalog Number: 50796060. Open, Classified |
KTT | K033476 |
| Jul 29, 2026 | Stryker GmbH Stryker Hoffmann II Connecting Rod Micro 3 x 50mm. Catalog Number: 50796050. Open, Classified |
KTT | K033476 |
| Jul 29, 2026 | Stryker GmbH Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number: 50796040. Open, Classified |
KTT | K033476 |
| Jul 29, 2026 | Stryker GmbH Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030. Open, Classified |
KTT | K033476 |
| Jul 14, 2026 | Orthofix U.S. LLC Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS
REF: M122, Unilateral orthopedic/trauma external fixation device Open, Classified |
KTT | K113770 |
| Jul 14, 2026 | Orthofix U.S. LLC Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS
REF: M111, Unilateral orthopedic/trauma external fixation device Open, Classified |
KTT | K113770 |
| Jul 14, 2026 | Orthofix U.S. LLC Orthofix MINIRAIL, SHORT, LENGTHENER
REF: M103, Unilateral orthopedic/trauma external fixation device Open, Classified |
KTT | K113770 |
| Jul 14, 2026 | Orthofix U.S. LLC Orthofix MINIRAIL, STANDARD LENGTHENER
Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device Open, Classified |
KTT | K113770 |
| Sep 3, 2025 | Medshape, INC. Medshape Universal Joints, REF: DNE-9000-UJ Open, Classified |
KTT | K151580 |
| Jun 27, 2024 | Stryker GmbH Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System. Open, Classified |
KTT | None listed |
| Jun 9, 2023 | New Standard Device Inc 'n'-Hole Post which is a component of the Revolution External Fixation System
Catalog Numbers:
100801,
100802,
100803,
100804,
100805 Open, Classified |
KTT | K181630 |
| Mar 1, 2023 | Stryker GmbH stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended to keep bone fragments/segments in a correct anatomical position until reliable bone consol Open, Classified |
KTT | K153377 |
| Feb 7, 2023 | Wishbone Medical, Inc. WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device
Type Part Number
XXS 10-702-080095-0
XS 10-702-095115-0
Short 10-7 Open, Classified |
KTT | K193368 |
| Jun 29, 2022 | OrthoPediatrics Corp Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm
Model: K400-18BN Open, Classified |
KTT | K151881 |
| Dec 21, 2021 | Howmedica Osteonics Corp. Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL, Catalog Number 6704-0-110 Open, Classified |
KTT | K872224 |
| Jun 17, 2021 | Medicalplastic S.R.L. Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434 Open, Classified |
KTT | K093047 |
| Dec 28, 2020 | New Standard Device Inc Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic.
Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030
Metalogix Self-Drill Half-Pin 5x40x215mm RE Open, Classified |
KTT | K181630 |
| Jun 8, 2020 | New Standard Device Inc 1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System Completed |
KTT | K181630 |
| Oct 10, 2019 | Zimmer Biomet, Inc. CABLE-READY SHORT GTR and CABLE-READY LONG GTR, Item Nos. 00223200201
00223200202 Terminated |
KTT | K151907 |
| Oct 10, 2019 | Zimmer Biomet, Inc. Various fixation systems and accessories, Item Nos. 00118100522
00118100527
00118100530
00118100532
00118100535
00118100537
00118100540
00118100542
00118100550
00118100552
00118100562
00118100565
0011 Terminated |
KTT | K090596 K150818 +1 |
| Aug 21, 2019 | Zimmer Biomet, Inc. HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit)
Item Nos: HAA60-09030
HAA60-09040
HAA60-10030
HAA60-10040
HAA60-11030
HAA60-11040
HAA60-11050
HAA60-12040
HAA60-12060 Terminated |
KTT | K003397 K013503 +2 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-93601, GALAXY WRIST STERILE KIT, UDI: (01)18054242511656 Terminated |
KTT | K141760 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-93504,
ELBOW STERILE KIT, UDI: (01)18054242511533 Terminated |
KTT | K113770 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-93503US,
ANKLE TRANSFIX PIN STERILE KIT, UDI: (01)18054242511304 Terminated |
KTT | K113770 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref:99-93503 ,
ANKLE STERILE KIT, UDI: (01)18033509859922 Terminated |
KTT | K113770 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-93502US, TIBIA FEMUR DIAPHYSEAL STERILE KIT, UDI: (01)18054242S511298 Terminated |
KTT | K113770 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-93502JP, LOWER LIMB DIAPHYSEAL STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510895 Terminated |
KTT | K113770 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-93502,
LOWER LIMB DIAPHYSEAL STERILE KIT, RX ONLY, UDI: (01)18033509859915 Terminated |
KTT | K113770 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-93501US, PELVIS STERILE KIT, RX ONLY, UDI: (01)180S4242S11281 Terminated |
KTT | K113770 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-93501JP, PELVIS STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510888 Terminated |
KTT | K113770 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-93501, PELVIS STERILE KIT, RX ONLY, UDI: (01)18033509859908 Terminated |
KTT | K113770 |
| Aug 28, 2018 | Stryker GmbH Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935-0-040. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of: Terminated |
KTT | K163656 |
| Aug 28, 2018 | Stryker GmbH Hoffman LRF Hexapod Strut, Extra Short 131mm-191mm, Model Number 4935-0-030. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of: Terminated |
KTT | K163656 |
| Aug 28, 2018 | Stryker GmbH Hoffman LRF Hexapod Strut, Extra Short 105mm-139mm, Model Number 4935-0-020. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of: Terminated |
KTT | K163656 |
| Aug 28, 2018 | Stryker GmbH Hoffman LRF Hexapod Strut, Extra Short 89mm-109mm, Model Number 4935-0-010. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of: O Terminated |
KTT | K163656 |
| Jul 26, 2018 | Stryker GmbH Hoffmann LRF Hexapod Software
Catalog #: 983031
Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002 Terminated |
KTT | K163656 |
| Mar 12, 2018 | Stryker GmbH Hinge Coupling Hoffmann LRF Catalog # 4933-0-800
Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, bone and soft tissue reconstruction in pediat Terminated |
KTT | K113327 |
| Jan 30, 2018 | Orthofix Srl TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 140 MM, 160 MM, 180 MM, 200 MM.
The TL-HEX TrueLock Hexapod System (TL-HEX) consists of rings, foot plates an Terminated |
KTT | K170650 |
| Jul 5, 2017 | Orthofix Srl Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal Tibia Sterile Kit, Galaxy UNYCO Mini Kit Instruments Sterile, Galaxy UNYCO Diaph Terminated |
KTT | K142052 K153233 |
| Apr 28, 2017 | Zimmer Biomet, Inc. 4.5 BROAD SCP PLT 26-H STER Terminated |
KTT | K830196 |
| Apr 28, 2017 | Zimmer Biomet, Inc. VERSA-FX II STD TUBE 130DX16H, 130DX18H, 130DX20H,
135DX16H, 135DX18H, 135DX20H, 140DX16H, 140DX18H, 140DX20H, 145DX16H, 145DX18H, 145DX20H, 150DX16H, 150DX18H, 150DX20H Terminated |
KTT | K830196 |
| Apr 28, 2017 | Zimmer Biomet, Inc. VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H,
95DX20H, 95DX22H Terminated |
KTT | K830196 |
| Apr 26, 2017 | Stryker Howmedica Osteonics Corp. Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-401, NDC (01)07613327131475(10)V07241
Product Usage:
Intended for fixation of fractures, joint contractures, fusions, limb Terminated |
KTT | K153377 |
| Jul 20, 2016 | Integra LifeSciences Corp. Integra External Fixation System Slotted Post - Small Catalogue #12224228; Integra External Fixation System Slotted Post Large Catalogue #12224229 Terminated |
KTT | K140463 K160830 |
| Jul 20, 2016 | Integra LifeSciences Corp. Integra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catalogue #12224218 ; Integra External Fixation System Universal Wire Fixation Bolt - 23 mm Catalogue #12224219 Terminated |
KTT | K140463 K160830 |
| Jul 1, 2016 | Integra LifeSciences Corp. Integra External Fixation System Rocker Bottom Model # 12225400.
For use in the treatment of bone conditions amenable to treatment by the use of external fixation. Terminated |
KTT | K140463 |
| May 26, 2016 | Biomet, Inc. Various trauma and sports medicine instruments and implants.
Appliance, fixation, nail/blade/plate combination, multiple component. Terminated |
KTT | K964880 |
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