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)
May 16, 2016Zimmer Manufacturing B.V.
VersaFx Femoral Fixation System Hex head compression screw 4.7 mm dia. 2 inch (51 mm) length 47116202400
Terminated
KTTK150818
Mar 12, 2016Zimmer Manufacturing B.V.
Product 65 consists of all product under product code: KTT and same usage: Item no: 119413594 VERSA-FX II KEYLESS SHORT 119413595 VERSA-FX II KEYLESS SHORT 119413596 VERSA-FX II KEYLESS SHORT 1194130
Terminated
KTTK150818
Mar 12, 2016Zimmer Manufacturing B.V.
Product 41 consists of all product under product code: KTT and same usage: Item no: 119301042 LAG SCR 12.7D X 100MM STA 119301045 LAG SCR 12.7D X 105MM STA 119301047 LAG SCR 12.7D X 110MM STA 119301
Terminated
KTTK150818
Mar 12, 2016Zimmer Manufacturing B.V.
Product 31 consists of all product under product code: KTT and same usage: Item no: 118113003 FREE-LOCK TUBE & SCP PLAT 118113502 FREE-LOCK TUBE & SCP PLAT 118113503 FREE-LOCK TUBE & SCP PLAT 118114
Terminated
KTTK150818
Mar 12, 2016Zimmer Manufacturing B.V.
Product 30 consists of all product under product code: KTT and same usage: Item no: 118100527 FREE-LOCK LAG SCREW, 12.7 118100535 FREE-LOCK LAG SCREW, 12.7 118100540 FREE-LOCK LAG SCREW, 12.7 118100
Terminated
KTTK830196
Mar 12, 2016Zimmer Manufacturing B.V.
Product 20 consists of all prod oct under poduct code: KTT and same usage: Item no: 47116201900 COMPRESSION SCREW 1/2IN 47116202300 COMPRESSION SCREW 1-1/2IN 47116202200 COMPRESSION SCREW 1-1/4IN 47
Terminated
KTTK150818
Aug 24, 2015Synthes (USA) Products LLC
Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large) ; (S) intended to stabilize and provide treatment for fractures of the small bones, such as the hand, wrist, forea
Terminated
KTTK030390
K031428 +3
Jun 9, 2015Biomet, Inc.
Unilateral external fixation ankle clamp Product Usage: Unilateral external fixation for use treatment of bone conditions amenable to treatment by use of external fixation modality
Terminated
KTTK111376
Jun 19, 2014Synthes, Inc.
Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.
Terminated
KTTK030390
K082650 +3
Jun 4, 2014Small Bone Innovations, Inc.
SBi RingFix Olive Wires Product Usage: These are temporary devices indicated for: osteosynthesis of fractures with small osteoarticular fragments, fixation of open and closed fractures, arthrodesis,
Terminated
KTTK071394
Feb 20, 2014Zimmer, Inc.
COMPRESSION SCREW (1/2, 1-1/2, 1-1/4, 1-3/4, 1. 2. 3/4 IN)
Terminated
KTTNone listed
Feb 20, 2014Zimmer, Inc.
VERSA-FX KEYLESS 90D X 8 and X 11, VERSA-FX KEYLESS 95D X 8, X 11, and X 14, VERSA-FX KEYLESS 140D X 4 and X 5, VERSA-FX KEYLESS 135D X 4 and X 5, VERSA-FX SHORT TUBE, 130D, 135D and 140D, VERSA-FX ST
Terminated
KTTNone listed
Feb 20, 2014Zimmer, Inc.
VERSA-FX II KEYLESS TUBE, VERSA-FX II KEYLESS SHORT, VERSA-FX II SHORT TUBE PL, VERSA-FX II STD TUBE PLAT and VERSA-FX II SUPRACONDYLR Item codes starting with 0011930, 0011931 and 0011941
Terminated
KTTK954555
Feb 20, 2014Zimmer, Inc.
FREE-LOCK LAG SCREW, 12.7, FREE-LOCK LAG SCREW, 15.8, FREE-LOCK SUPRACOND TUBE and FREE-LOCK TUBE & SCP PLAT. Items starting with codes 0011810 and 0011811.
Terminated
KTTK830196
Dec 10, 2013Synthes USA HQ, Inc.
Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is used for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, medial and lateral distal femur
Terminated
KTTK023941
Nov 27, 2013Synthes USA HQ, Inc.
Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fractures.
Terminated
KTTK041911
Sep 25, 2013Synthes USA HQ, Inc.
Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of fractures of the distal humerus, olecranon, and ulna in adults and adolescents (12
Terminated
KTTK033995
Aug 26, 2013Zimmer, Inc.
VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short - low profile, different hole/length combinations (4/86, 5/102 and 6/118), different degree angles (130, 135, 140, 145 an
Terminated
KTTK830196
Aug 26, 2013Zimmer, Inc.
VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short low profiles, several holes/length combinations (2/54, 3/70, 4/86, 5/102, 6/118) and several angles (130, 135, 140, 145 a
Terminated
KTTK830196
Aug 26, 2013Zimmer, Inc.
VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW, several length (55 mm to 155 mm), diameters (12.7 mm and 15.8 mm) and short thread, standard thread and large thread. Item codes starting with
Terminated
KTTK830196
Aug 26, 2013Zimmer, Inc.
Free Lock Femoral Hip Fixation System Compression Tube/Plate, different length (59, 75, 91, 107, 123 mm), holes (2, 3, 4, 5, 6) and degree angles (130, 135, 140, 145 and 150). Item codes starting with
Terminated
KTTK830196
Aug 26, 2013Zimmer, Inc.
Free Lock Femoral Hip Fixation System Compression Lag Screw . Several lengths (55 to 150 mm) and diameters (12.7 and 15. 8 mm). Item codes starting with 00-1181-05, 00-1181-10 and 00-1181-15. ZIMMER
Terminated
KTTK830196
Jul 29, 2013Synthes USA HQ, Inc.
Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixation is intended for use to provide treatment for long bone and
Open, Classified
KTTK082650
Mar 11, 2013Synthes USA HQ, Inc.
Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures
Terminated
KTTK082650
Jan 17, 2013Stryker Howmedica Osteonics Corp.
Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003.
Terminated
KTTK113327
Dec 17, 2012Biomet, Inc.
EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral external fixator rail, modular bone screw clamps, and compression and distraction units. The
Terminated
KTTK000083
Nov 13, 2012Synthes USA HQ, Inc.
Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007. Intended for use to provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the co
Terminated
KTTK082650
Nov 8, 2012Stryker Howmedica Osteonics Corp.
Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seizach Distributed in the USA by Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The use of external devices pro
Terminated
KTTK113327
Jun 17, 2011Kinamed Inc
Kinamed SuperCable Grip and Plate System Driver, 3.5mm Hex, Catalog Number: 35-860-2060 The driver is intended to be used in conjunction with compression and locking bone screws for fixation of long
Terminated
KTTK072250
Aug 18, 2009Stryker Howmedica Osteonics Corp.
Dall Miles Cable Grip System; Catalog number 6704-0-210; Stryker Ireland. The Dall-Miles Recon and Trauma Cable System provides the surgeon with a variety of methods for achieving trochanteric reatta
Terminated
KTTK872224
May 29, 2009Synthes Spine
Square Nut MR Safe, Catalog Number 03.311.060. The Square Nut MR Safe is used in conjunction with Synthes Distraction Osteogenesis Ring Systems. It can be used to secure components together or as a
Terminated
KTTK051600
Jan 13, 2009Sterilmed Inc
External Fixation Device Model #'s: ORT99-36501 SYN390.005 SYN390.008 SYN394.84 SYN394.85 and SYN394.86 Intended for use in the construction of an external fixation frame for treatment of a various f
Terminated
KTTK051957
Sep 16, 2008Stryker Howmedica Osteonics Corp.
Short Barrel Sideplate, Omega + 140 degrees, 4 slots; The Omega Plus Compression Screw system consists of a series of lag screws, proximal hip side plates, supracondylar side plates, and compression s
Terminated
KTTK850886
K872223 +3
Jan 24, 2008Depuy Orthopaedics, Inc.
Depuy TK2 Compression Hip Screw trauma plate, Short Barrel, 135 DEG, 4H-92.6mm, sterile; REF 8315-35-104, DePuy Orthopaedics, Inc., Warsaw, IN 46581
Terminated
KTTK972629
Jan 24, 2008Depuy Orthopaedics, Inc.
Depuy TK2 Compression Hip Screw trauma plate, Standard Barrel,135 Degree, 4H-92.6mm, sterile; REF 8315-35-004, DePuy Orthopaedics, Inc., Warsaw, IN 46581
Terminated
KTTK972629
Dec 8, 2007Plus Orthopedics USA
Plus Orthopedics Gliding Nail 17mm proximal / 11mm distal, 125 degrees, 180mm; Model Number: 0132073, Plus Orthopedics USA, San Diego, CA 92121
Terminated
KTTK020240
Nov 15, 2006EBI, L.P.
VHS Pediatric Plate (for hip screw system) Ref 200501, VHS Pediatric Plate Stainless Steel Rx only, sterile
Terminated
KTTK011603
Nov 15, 2006EBI, L.P.
VHS Pediatric Hip Screw System Ped VHS, Lag Screw Ref # 200516 Stainless Steel, Rx only
Terminated
KTTK011603
Jun 2, 2006Plus Orthopedics USA
Model Number: GNRADIOLUCENTGUIDE (Gliding Nail Radiolucent Guide), instrument set that contains one unit of each of the following instrument: 1130020-A: GNp Carbon Targeting Handle 1130021-A: GN Ad
Terminated
KTTNone listed

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