Panels › Orthopedic › Product code HRS · Class 2
Plate, Fixation, Bone
Regulation 888.3030
64510(k)s in 12 months (1,334 all time)
20recalls in 12 months (288 all time)
277recalls that name a 510(k)
Top companies in HRS
| Company | 510(k)s | Recalls |
|---|---|---|
| Synthes | 104 | 8 |
| Smith & Nephew | 37 | 16 |
| Biomet | 21 | 28 |
| Wrightmedicaltechnologyinc | 45 | 0 |
| Zimmer GmbH | 32 | 12 |
| Arthrex, Inc. | 40 | 3 |
| Wright Medical Technology Inc | 0 | 43 |
| DePuy Orthopaedics, Inc. | 18 | 14 |
| Medartis AG | 32 | 0 |
| TriMed, Inc. | 25 | 6 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 7, 2018 | Orthofix, Inc Rival Reduce Kit Locking and Non-Locking Screw D 2.0MM, D 2.7MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-011C Terminated |
HRS | K142135 |
| Apr 16, 2018 | TriMed Inc. Ulnar Osteotomy Compression Plate, Short
Model: UOCP-S
Product Usage:
The UOCP-S is provided non-sterile with the required fixation screws and surgical instrumentation. The TriMed Ulnar Osteotomy Pla Terminated |
HRS | K043263 |
| Mar 20, 2018 | Epic Extremity, LLC Epic Extremity Plate System,10x10 Plate Caddy, Part 2111-1010 with 2.7 and 3.5mm Non-Locking Screw (2001-27XX-N & 2001-35XX-N) Terminated |
HRS | K153340 |
| Mar 20, 2018 | Epic Extremity, LLC Epic Extremity Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Extended Butterfly Plate (2000-5002) Terminated |
HRS | K153340 |
| Dec 11, 2017 | Smith & Nephew, Inc. smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STOUT STRAIGHT PLATE, 8 HOLE VLP(R) MIN-MOD, REF 74442030, QTY: (1), STERILE R
Terminated |
HRS | K132886 |
| Dec 11, 2017 | Smith & Nephew, Inc. smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STRAIGHT PLATE, 8 HOLE VLP(R) MIN-MOD, REF 74442024, QTY: (1), STERILE R
Bone Terminated |
HRS | K132886 |
| Nov 29, 2017 | Smith & Nephew, Inc. smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx only, (01)00885556456446(10), (11)171116
Bone plates and bone screws from the EVOS Mini-Fragme Terminated |
HRS | K140814 |
| Oct 25, 2017 | Zimmer Biomet, Inc. A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403 Terminated |
HRS | K093474 K111663 |
| Jul 13, 2017 | In2Bones, SAS Non-Locking screws in the following lengths:
(a) NEO(R) 0.27 - 10 mm, REF W27 ST010
(b) NEO(R) 0.27 - 12 mm, REF W27 ST012
(c) DRP 0.27 - 12 mm, REF W27 ST012
(d) NEO(R) 0.27 - 14 mm, REF W27 ST01 Terminated |
HRS | K160995 |
| Apr 14, 2017 | Smith & Nephew, Inc. PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH, SST PLATE, REF 71823114, QTY: (1) NON-STERILE, Rx only, Smith & nephew, Inc., Memphis TN 38116 Terminated |
HRS | K092015 |
| Mar 9, 2017 | Smith & Nephew, Inc. Peri-Loc(R) VLP 3.5 MM X 6 MM SELF-TAPPING CORTEX SCREW, QTY: (1), STERILE R, REF 71801306
Orthopedic Terminated |
HRS | K062216 |
| Feb 14, 2017 | Acumed LLC 6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates for the pelvic ring are a series of plates with varying lengths that function as internal fixation devices for fractures, fusions and Terminated |
HRS | K122538 |
| Jan 6, 2017 | In2Bones, SAS NEOVIEW(R) SCREWS SET, REF W27 ST900, STERILE R
The NEOVIEW Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the dist Terminated |
HRS | K160995 |
| Jan 6, 2017 | In2Bones, SAS NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, In2Bones, 28 chemin du petit bois, 69130 Ecully - France
The NEOVIEW Plating System is intended for fixation of intra-articular and extraarticular fracture Terminated |
HRS | K160995 |
| Jan 6, 2017 | In2Bones, SAS SCREW 02.7-12MM LOCKING, REF W27 ST112: a) DRP, b) NEO, In2Bones, 28 chemin du petit bois, 69130 Ecully - France
The NEOVIEW Plating System is intended for fixation of intra-articular and extraartic Terminated |
HRS | K160995 |
| Nov 8, 2016 | Wright Medical Technology, Inc. CPS CALCANEAL PLATE SML 54MM, Part Number DCS2805001 Terminated |
HRS | K061808 |
| Nov 8, 2016 | Wright Medical Technology, Inc. EVANS OPENING WEDGE PLATE 10MM, Part Number 58S30010 Terminated |
HRS | None listed |
| Aug 29, 2016 | Trimed Inc TriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10
Contoured plate with offset screw holes. The plate is 103 mm in length, 1.3 mm thick and 9.6 mm wide. The part is made of surgical steel conforma Terminated |
HRS | K060041 |
| Aug 11, 2016 | Synthes (USA) Products LLC Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone, Orthopedic Devices
Terminated |
HRS | K012114 K050110 +3 |
| Jun 10, 2016 | Synthes (USA) Products LLC LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile; Indicated for fractures, osteotomies, and non-unions of the radius and other small bones. Terminated |
HRS | K070946 |
| May 26, 2016 | Biomet, Inc. Various trauma and sports medicine instruments and implants.
Plate, fixation, bone. Terminated |
HRS | K093880 K111663 |
| May 10, 2016 | Integra LifeSciences Corp. TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Screws
The FS2030 Depth Gauge is used by the physician to determine the correct screw length when implanting a 2.0 or 2.5mm TS Terminated |
HRS | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 58 consists of all product under product code: HRS and same usage:
Item no:
234800904 PROXIMAL DORSAL ULNA PLT
234800906 PROXIMAL DORSAL ULNA PLT
234800908 PROXIMAL DORSAL ULNA PLT
234800910 Terminated |
HRS | K150121 |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 27 consists of all product under product code: HSB and same usage:
Item no:
234703104 DISTAL MEDIAL FEMORAL CON
234703206 DISTAL MEDIAL FEMORAL CON
234703208 DISTAL MEDIAL FEMORAL CON
234800 Terminated |
HRS | K150121 |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 24 consists of all product under product code: HRS and same usage:
Item no:
234703104 DISTAL MEDIAL FEMORAL CON
234703206 DISTAL MEDIAL FEMORAL CON
234703208 DISTAL MEDIAL FEMORAL CON
234800 Terminated |
HRS | K150121 |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 9 consists of all product under HRS, and same usage:
Item no:
47494502601 4.5 BROAD SCP PLT, 26 HOL
Product Usage:
Temporary internal fixation devices designed to stabilize fractures du Terminated |
HRS | None listed |
| Jan 11, 2016 | Arthrex, Inc. Arthrex Deltoid Ligament Reconstruction Implant System.
Intended as a fixation post, a distribution bridge or for distributing suture tension over areas of ligament or tendon repair utilizing titaniu Terminated |
HRS | K031666 |
| Dec 18, 2015 | Biomet, Inc. A.L.P.S. 4.0mm Cancellous Locking Screws
intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones. Terminated |
HRS | K072083 K072832 +2 |
| Dec 9, 2015 | Zimmer Biomet, Inc. Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate
Straight 11 Holes 144mm Length
Zimmer Universal Locking System 3.5mm Locking Dual Compression Plate
8 Holes 105mm Length.
Indicated Terminated |
HRS | K060710 |
| Dec 4, 2015 | Smith & Nephew, Inc. Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, RIGHT - 62 MM, STERILE R, Rx only, REF Numbers: 71863114 Bone fixation plate Terminated |
HRS | K083032 |
| Dec 4, 2015 | Smith & Nephew, Inc. Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT - 62 MM, STERILE R, Rx only, REF Numbers: 71863110 Bone fixation plate Terminated |
HRS | K083032 |
| Nov 6, 2015 | Synthes (USA) Products LLC Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/PLATE 231mm 6HOLES/5.0mm ROD/17HOLES. Orthopedic implant. Terminated |
HRS | K915818 |
| Oct 30, 2015 | Synthes (USA) Products LLC 2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of Terminated |
HRS | K063049 |
| Sep 28, 2015 | Synthes (USA) Products LLC Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile and Synthes 2.7MM/3.5MM VA-LCP Extended Medial Distal Humerus Plates 10H/RT/189mm-Sterile
The Synthes 2.7 mm/3.5 mm Varia Terminated |
HRS | K120070 |
| Sep 18, 2015 | OrthoPediatrics Corp 3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System
Part number 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw. Used in pediatric orthopedics. Terminated |
HRS | K111086 |
| Sep 4, 2015 | Trilliant Surgical Ltd. 2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit, Model Number 310-30-003, Lot Number TSL002605, NON-STERILE. For use with the Gridlock Plating System for trauma and reconstructive procedures of small Terminated |
HRS | K121452 |
| Sep 1, 2015 | Wright Medical Technology, Inc. CrossCHECK Non-Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-N3008; 3.0 x 10 mm, REF CCP-N3010; 3.0 x 12 mm, REF CCP-N3012; 3.0 x 14 mm, REF CCP-N3014l; 3.0 x 16 mm, REF CCP-N3016; 3.0 x 1 Terminated |
HRS | K132594 |
| Sep 1, 2015 | Wright Medical Technology, Inc. CrossCHECK Locking Screw in the following sizes:
3.0 x 8 mm, REF CCP-L3008; 3.0 x 10 mm, REF CCP-L3010; 3.0 x 12 mm, REF CCP-L3012; 3.0 x 14 mm, REF CCP-L3014; 3.0 x 16 mm, REF CCP-L3016; 3.0 x 18 mm Terminated |
HRS | K132594 |
| Aug 31, 2015 | Trilliant Surgical Ltd. 7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONLY; 9 Hole VL Gridlock Fibula Plate, Part # 300-60-002 NON-STERILE SINGLE USE ONLY; 11 Hole VL Gridlock Fibula Plate, Part # Terminated |
HRS | K121452 |
| Jul 10, 2015 | Biomet, Inc. A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw Terminated |
HRS | K111663 |
| Jul 8, 2015 | Biomet, Inc. A.L.P.S. Foot Locking Calcaneus Plate,Small-Right.
Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries. Terminated |
HRS | K093474 K111663 |
| Apr 22, 2015 | Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, Y-PLATE CX, REF CCP-YPX1.
Orthopedic use. Terminated |
HRS | K132594 |
| Apr 22, 2015 | Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, Utility Plate, 7-Hole, REF CCP-UTN7.
Orthopedic use. Terminated |
HRS | K132594 |
| Apr 22, 2015 | Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, Utility Plate, 6-Hole, REF CCP-UTN6.
Orthopedic use. Terminated |
HRS | K132594 |
| Apr 22, 2015 | Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, Utility Plate, 5-Hole, REF CCP-UTN5.
Orthopedic use. Terminated |
HRS | K132594 |
| Apr 22, 2015 | Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, Utility Plate, 4-Hole, REF CCP-UTN4.
Orthopedic use. Terminated |
HRS | K132594 |
| Apr 22, 2015 | Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, Utility Plate, 3-Hole, REF CCP-UTN3.
Orthopedic use. Terminated |
HRS | K132594 |
| Apr 22, 2015 | Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, Utility Plate, 2-Hole, REF CCP-UTN2.
Orthopedic use. Terminated |
HRS | K132594 |
| Apr 22, 2015 | Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, MTP CX Plate, Right, REF CCP-MPX1R.
Orthopedic use. Terminated |
HRS | K132594 |
| Apr 22, 2015 | Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, MTP CX Plate, Left, REF CCP-MPX1L.
Orthopedic use. Terminated |
HRS | K132594 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.