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) |
|---|---|---|---|
| May 16, 2016 | Zimmer Manufacturing B.V. VersaFx Femoral Fixation System
Hex head compression screw 4.7 mm dia. 2 inch (51 mm) length 47116202400 Terminated |
KTT | K150818 |
| Mar 12, 2016 | Zimmer 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 |
KTT | K150818 |
| Mar 12, 2016 | Zimmer 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 |
KTT | K150818 |
| Mar 12, 2016 | Zimmer 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 |
KTT | K150818 |
| Mar 12, 2016 | Zimmer 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 |
KTT | K830196 |
| Mar 12, 2016 | Zimmer 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 |
KTT | K150818 |
| Aug 24, 2015 | Synthes (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 |
KTT | K030390 K031428 +3 |
| Jun 9, 2015 | Biomet, 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 |
KTT | K111376 |
| Jun 19, 2014 | Synthes, Inc. Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components. Terminated |
KTT | K030390 K082650 +3 |
| Jun 4, 2014 | Small 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 |
KTT | K071394 |
| Feb 20, 2014 | Zimmer, Inc. COMPRESSION SCREW (1/2, 1-1/2, 1-1/4, 1-3/4, 1. 2. 3/4 IN) Terminated |
KTT | None listed |
| Feb 20, 2014 | Zimmer, 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 |
KTT | None listed |
| Feb 20, 2014 | Zimmer, 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 |
KTT | K954555 |
| Feb 20, 2014 | Zimmer, 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 |
KTT | K830196 |
| Dec 10, 2013 | Synthes 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 |
KTT | K023941 |
| Nov 27, 2013 | Synthes USA HQ, Inc. Synthes 4.5 mm LCP Curved Condylar Plate
Intended for buttressing multifragmentary distal femur fractures. Terminated |
KTT | K041911 |
| Sep 25, 2013 | Synthes 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 |
KTT | K033995 |
| Aug 26, 2013 | Zimmer, 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 |
KTT | K830196 |
| Aug 26, 2013 | Zimmer, 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 |
KTT | K830196 |
| Aug 26, 2013 | Zimmer, 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 |
KTT | K830196 |
| Aug 26, 2013 | Zimmer, 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 |
KTT | K830196 |
| Aug 26, 2013 | Zimmer, 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 |
KTT | K830196 |
| Jul 29, 2013 | Synthes 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 |
KTT | K082650 |
| Mar 11, 2013 | Synthes 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 |
KTT | K082650 |
| Jan 17, 2013 | Stryker Howmedica Osteonics Corp. Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003. Terminated |
KTT | K113327 |
| Dec 17, 2012 | Biomet, 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 |
KTT | K000083 |
| Nov 13, 2012 | Synthes 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 |
KTT | K082650 |
| Nov 8, 2012 | Stryker 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 |
KTT | K113327 |
| Jun 17, 2011 | Kinamed 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 |
KTT | K072250 |
| Aug 18, 2009 | Stryker 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 |
KTT | K872224 |
| May 29, 2009 | Synthes 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 |
KTT | K051600 |
| Jan 13, 2009 | Sterilmed 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 |
KTT | K051957 |
| Sep 16, 2008 | Stryker 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 |
KTT | K850886 K872223 +3 |
| Jan 24, 2008 | Depuy 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 |
KTT | K972629 |
| Jan 24, 2008 | Depuy 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 |
KTT | K972629 |
| Dec 8, 2007 | Plus Orthopedics USA Plus Orthopedics Gliding Nail 17mm proximal / 11mm distal, 125 degrees, 180mm; Model Number: 0132073, Plus Orthopedics USA, San Diego, CA 92121 Terminated |
KTT | K020240 |
| Nov 15, 2006 | EBI, L.P. VHS Pediatric Plate (for hip screw system)
Ref 200501, VHS Pediatric Plate Stainless Steel
Rx only, sterile Terminated |
KTT | K011603 |
| Nov 15, 2006 | EBI, L.P. VHS Pediatric Hip Screw System
Ped VHS, Lag Screw
Ref # 200516
Stainless Steel, Rx only Terminated |
KTT | K011603 |
| Jun 2, 2006 | Plus 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 |
KTT | None listed |
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