ClearanceBrief
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)
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Top companies in KTT

DateFirm and productCodeLinked 510(k)
Jul 29, 2026Stryker GmbH
Stryker Hoffmann II Connecting Rod Micro 3 x 150mm. Catalog Number: 50796150.
Open, Classified
KTTK033476
Jul 29, 2026Stryker GmbH
Stryker Hoffmann II Connecting Rod Micro 3 x 120mm. Catalog Number: 50796120.
Open, Classified
KTTK033476
Jul 29, 2026Stryker GmbH
Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090.
Open, Classified
KTTK033476
Jul 29, 2026Stryker GmbH
Stryker Hoffmann II Connecting Rod Micro 3 x 60mm. Catalog Number: 50796060.
Open, Classified
KTTK033476
Jul 29, 2026Stryker GmbH
Stryker Hoffmann II Connecting Rod Micro 3 x 50mm. Catalog Number: 50796050.
Open, Classified
KTTK033476
Jul 29, 2026Stryker GmbH
Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number: 50796040.
Open, Classified
KTTK033476
Jul 29, 2026Stryker GmbH
Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030.
Open, Classified
KTTK033476
Jul 14, 2026Orthofix U.S. LLC
Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device
Open, Classified
KTTK113770
Jul 14, 2026Orthofix U.S. LLC
Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device
Open, Classified
KTTK113770
Jul 14, 2026Orthofix U.S. LLC
Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation device
Open, Classified
KTTK113770
Jul 14, 2026Orthofix U.S. LLC
Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device
Open, Classified
KTTK113770
Sep 3, 2025Medshape, INC.
Medshape Universal Joints, REF: DNE-9000-UJ
Open, Classified
KTTK151580
Jun 27, 2024Stryker GmbH
Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.
Open, Classified
KTTNone listed
Jun 9, 2023New 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
KTTK181630
Mar 1, 2023Stryker 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
KTTK153377
Feb 7, 2023Wishbone 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
KTTK193368
Jun 29, 2022OrthoPediatrics Corp
Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
Open, Classified
KTTK151881
Dec 21, 2021Howmedica Osteonics Corp.
Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL, Catalog Number 6704-0-110
Open, Classified
KTTK872224
Jun 17, 2021Medicalplastic S.R.L.
Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434
Open, Classified
KTTK093047
Dec 28, 2020New 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
KTTK181630
Jun 8, 2020New Standard Device Inc
1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System
Completed
KTTK181630
Oct 10, 2019Zimmer Biomet, Inc.
CABLE-READY SHORT GTR and CABLE-READY LONG GTR, Item Nos. 00223200201 00223200202
Terminated
KTTK151907
Oct 10, 2019Zimmer Biomet, Inc.
Various fixation systems and accessories, Item Nos. 00118100522 00118100527 00118100530 00118100532 00118100535 00118100537 00118100540 00118100542 00118100550 00118100552 00118100562 00118100565 0011
Terminated
KTTK090596
K150818 +1
Aug 21, 2019Zimmer 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
KTTK003397
K013503 +2
Sep 27, 2018Orthofix Srl
ORTHOFIX Catalogue Number: ref: 99-93601, GALAXY WRIST STERILE KIT, UDI: (01)18054242511656
Terminated
KTTK141760
Sep 27, 2018Orthofix Srl
ORTHOFIX Catalogue Number: ref: 99-93504, ELBOW STERILE KIT, UDI: (01)18054242511533
Terminated
KTTK113770
Sep 27, 2018Orthofix Srl
ORTHOFIX Catalogue Number: ref: 99-93503US, ANKLE TRANSFIX PIN STERILE KIT, UDI: (01)18054242511304
Terminated
KTTK113770
Sep 27, 2018Orthofix Srl
ORTHOFIX Catalogue Number: ref:99-93503 , ANKLE STERILE KIT, UDI: (01)18033509859922
Terminated
KTTK113770
Sep 27, 2018Orthofix Srl
ORTHOFIX Catalogue Number: ref: 99-93502US, TIBIA FEMUR DIAPHYSEAL STERILE KIT, UDI: (01)18054242S511298
Terminated
KTTK113770
Sep 27, 2018Orthofix Srl
ORTHOFIX Catalogue Number: ref: 99-93502JP, LOWER LIMB DIAPHYSEAL STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510895
Terminated
KTTK113770
Sep 27, 2018Orthofix Srl
ORTHOFIX Catalogue Number: ref: 99-93502, LOWER LIMB DIAPHYSEAL STERILE KIT, RX ONLY, UDI: (01)18033509859915
Terminated
KTTK113770
Sep 27, 2018Orthofix Srl
ORTHOFIX Catalogue Number: ref: 99-93501US, PELVIS STERILE KIT, RX ONLY, UDI: (01)180S4242S11281
Terminated
KTTK113770
Sep 27, 2018Orthofix Srl
ORTHOFIX Catalogue Number: ref: 99-93501JP, PELVIS STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510888
Terminated
KTTK113770
Sep 27, 2018Orthofix Srl
ORTHOFIX Catalogue Number: ref: 99-93501, PELVIS STERILE KIT, RX ONLY, UDI: (01)18033509859908
Terminated
KTTK113770
Aug 28, 2018Stryker 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
KTTK163656
Aug 28, 2018Stryker 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
KTTK163656
Aug 28, 2018Stryker 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
KTTK163656
Aug 28, 2018Stryker 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
KTTK163656
Jul 26, 2018Stryker GmbH
Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002
Terminated
KTTK163656
Mar 12, 2018Stryker 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
KTTK113327
Jan 30, 2018Orthofix 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
KTTK170650
Jul 5, 2017Orthofix 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
KTTK142052
K153233
Apr 28, 2017Zimmer Biomet, Inc.
4.5 BROAD SCP PLT 26-H STER
Terminated
KTTK830196
Apr 28, 2017Zimmer Biomet, Inc.
VERSA-FX II STD TUBE 130DX16H, 130DX18H, 130DX20H, 135DX16H, 135DX18H, 135DX20H, 140DX16H, 140DX18H, 140DX20H, 145DX16H, 145DX18H, 145DX20H, 150DX16H, 150DX18H, 150DX20H
Terminated
KTTK830196
Apr 28, 2017Zimmer Biomet, Inc.
VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H
Terminated
KTTK830196
Apr 26, 2017Stryker 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
KTTK153377
Jul 20, 2016Integra LifeSciences Corp.
Integra External Fixation System Slotted Post - Small Catalogue #12224228; Integra External Fixation System Slotted Post Large Catalogue #12224229
Terminated
KTTK140463
K160830
Jul 20, 2016Integra 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
KTTK140463
K160830
Jul 1, 2016Integra 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
KTTK140463
May 26, 2016Biomet, Inc.
Various trauma and sports medicine instruments and implants. Appliance, fixation, nail/blade/plate combination, multiple component.
Terminated
KTTK964880

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