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) |
|---|---|---|---|
| Dec 16, 2019 | Synthes, Inc. 2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field. Terminated |
HRS | K103243 |
| Dec 5, 2019 | Stryker GmbH Stryker T2 Alpha Delta Strike Plate IMN Instruments - part of the IMN Instruments System and is used to support insertion and withdrawal of nails through the Targeting Device
Catalog Number: 2351-005 Terminated |
HRS | None listed |
| Oct 10, 2019 | Zimmer Biomet, Inc. NCB Straight Narrow Plate, various sizes, Item Nos. 0202267008
0202267010
0202267012
0202267014
0202267016
0202267018 Terminated |
HRS | K113718 |
| Oct 10, 2019 | Zimmer Biomet, Inc. Connection Screw for NCB Plate, Item No. 0202266002 Terminated |
HRS | K120772 |
| Oct 10, 2019 | Zimmer Biomet, Inc. Various temporary devices used during the implantation of the device system: bone fixation plates and screws, drill bits, manual surgical instruments for general use. Item Nos. 0202024301
0202024325
0 Terminated |
HRS | K100111 |
| Oct 10, 2019 | Zimmer Biomet, Inc. Periarticular locking plate elbow-sterile, Item Nos.
47235800503
47235800509
47235800511
47235800515
47235800519
47235800603
47235800605
47235800607
47235800609
47235800611
47235800615
47235800619
472 Terminated |
HRS | K082078 K141734 |
| Oct 10, 2019 | Zimmer Biomet, Inc. PROX LAT HUMERAL LOCK PLATE, Item Nos. 47235800104
47235800106
47235800108
47235800112
47235800116
47235800204
47235800206
47235800208
47235800212 Terminated |
HRS | K111039 |
| Oct 10, 2019 | Zimmer Biomet, Inc. PERI DIST VOLAR/DORSAL T/DORSAL DELTA RADIAL, Item Nos.
00234801303
00234801304
00234801306
00234801308
00234801310
00234801312
00234801403
00234801404
00234801406
00234801408
00234801410
00234801412 Terminated |
HRS | K142579 K150121 |
| Oct 10, 2019 | Zimmer Biomet, Inc. Periarticulare Plates - Elbow, Humeral and Ulna Plates, Item Nos. 00234800504
00234800506
00234800508
00234800510
00234800512
00234800514
00234800604
00234800606
00234800608
00234800610
00234800612
00 Terminated |
HRS | K150121 |
| Oct 10, 2019 | Zimmer Biomet, Inc. PERIARTICULAR PLATES SHOULDER, PERI PROX LAT HUMERAL, Item Nos. 00234800104
00234800106
00234800108
00234800110
00234800112
00234800114
00234800116
00234800204
00234800206
00234800208
00234800210
0023 Terminated |
HRS | K150121 |
| Oct 10, 2019 | Zimmer Biomet, Inc. Universal Locking Plates Sterile, Item Nos.
47492800207
47492800303
47492800402
47492800403
47492800407
47492800502
47492800503
47492800507
47492800603
47492800607
47492800613
47492800702
47492800703 Terminated |
HRS | K060710 K063303 +2 |
| Oct 10, 2019 | Zimmer Biomet, Inc. SM DIS VOL/DORS RAD LAT COL PLATE, Item Nos. 47235801404
47235802102
47235802103
47235802104
47235802106
47235802108
47235802203
47235802204
47235802206
47235802208
47235802210 Terminated |
HRS | K111039 |
| Oct 10, 2019 | Zimmer Biomet, Inc. DIST LAT FEM LCK PLATE STERILE, Item Nos.
47235710106
47235710110
47235710114
47235710118
47235710122
47235710210
47235710214
47235710218
47235710222 Terminated |
HRS | K111039 K141734 |
| Oct 10, 2019 | Zimmer Biomet, Inc. Prox Lat Tib Lock Plate and Dist Med Tib Lock Plate
Item Nos. 47235700306
47235700308
47235700310
47235700312
47235700314
47235700408
47235700410
47235700412
47235700414
47235700416
47235700504
47235 Terminated |
HRS | K111039 |
| Oct 10, 2019 | Zimmer Biomet, Inc. PERIARTICULAR PLATES - FEMUR, Item Nos. 00234700106
00234700108
00234700110
00234700112
00234700114
00234700116
00234700118
00234700206
00234700208
00234700210
00234700212
00234700214
00234700216
0023 Terminated |
HRS | K150121 |
| Oct 10, 2019 | Zimmer Biomet, Inc. Periarticular Plates - Tibial, Item Nos. 00234700304
00234700306
00234700308
00234700310
00234700312
00234700314
00234700316
00234700404
00234700406
00234700408
00234700410
00234700412
00234700414
002 Terminated |
HRS | K142579 K150121 |
| Oct 10, 2019 | Zimmer Biomet, Inc. ZPLP Fibular Plate, Item Nos. 00234701504
00234701506
00234701508
00234701510
00234701512
00234701516
00234701604
00234701606
00234701608
00234701610
00234701612
00234701614
00234701616
00234701702
00 Terminated |
HRS | K150121 |
| Oct 10, 2019 | Zimmer Biomet, Inc. NCB PERIPROSTHETIC, "NCB PP PROX FEM PLATE", Various sizes, Item Nos. 0202263009
0202263012
0202263015
0202263018
0202263021
0202263109
0202263112
0202263115
0202263118
0202263121
0202264009
020226401 Terminated |
HRS | K100111 |
| Oct 10, 2019 | Zimmer Biomet, Inc. NCB Proximal Lateral Tibia, "NCB-PT LAX PROX 3H TIBIA", Various Sizes, Item Nos. 0202261205
0202261207
0202261209
0202261213
0202261305
0202261307
0202261309
0202261313 Terminated |
HRS | K061211 |
| Oct 10, 2019 | TriMed Inc. TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert, or poly package containing varying amounts, Nonsterile, Single Use Only, Rx. The firm name on the label is TriM Terminated |
HRS | K951302 |
| Oct 9, 2019 | Nextremity Solutions Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile.
Catalog Number: STRM-NL-3550ST - Product Usage: The Stratum Foot Plating System is a plate and screws construct indicated for fixation of Terminated |
HRS | K182201 |
| May 9, 2019 | I.T.S. GmbH Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony consolidation has taken place. After this, the implant has Open, Classified |
HRS | K063166 |
| Jan 15, 2019 | Miami Device Solutions, LLC. Proximal Humerus Plate, 8 holes, Right, REF MDS130108R - Product Usage: The Proximal Humerus Plating System consists of plates, screws, and locking caps intended to provide internal fixation of fractu Terminated |
HRS | K141493 |
| Aug 24, 2018 | TriMed Inc. TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the TriMed Ankle Fixation System.
The HEX4.0 40 bone screw is a component of the TriMed Ankle Fixation System. Th Terminated |
HRS | K060041 |
| Aug 15, 2018 | TriMed Inc. TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only, (01) 00842188101281 - Product Usage: The OHOOKL is a semi-tubular design bone plate with two offset intramedullary tines Terminated |
HRS | K060041 |
| Jul 16, 2018 | NewDeal SA TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S,
150120S, 150110S, 150130S, 150200S, 150240S, 150242S, 150246S,
150250S, 150255S, 150260S, 150265S, 150270S, 150275S, 150280S,
150285S, 1 Terminated |
HRS | K093914 |
| Jul 16, 2018 | NewDeal SA Large QWIX, Model Numbers: 111740S, 111745S, 111750S, 111755S,
111760S, 111765S, 111770S, 111775S, 111780S, 111785S, 111790S,
111795S, 111800S, 111805S, 111810S, 111815S, 111820S, 121740S,
121745S, 1 Terminated |
HRS | K093914 |
| Jul 16, 2018 | NewDeal SA ADVANSYS MLP/DLP, Model Numbers: 181051S, 181052S, 181041S, 181042S, 181031S, 181032S, 181033S, 181021S, 181022S & 181023S Terminated |
HRS | K093914 |
| Jul 16, 2018 | NewDeal SA ADVANSYS TTC, Model Numbers: 181011S, 181012S, 181013S, 181014S,
181001S, 181002S, 181003S & 181004S Terminated |
HRS | K093914 |
| Jul 16, 2018 | NewDeal SA UNI-CP, Model Numbers: 330021S, 330023S, 330025S, 330030S, 330025S, 30030S, 330217S, 330220S, 330225S, 330230S, 330420S, 330425S, &
330430S Terminated |
HRS | K093914 |
| Jul 12, 2018 | Zimmer Biomet, Inc. Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic device used for stabilization and fixation of small bone fragments
Intended for stabilization and fixation of small bone f Terminated |
HRS | K081546 |
| Jun 7, 2018 | Orthofix, Inc Y-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-C-01001); b) Large (003-C-02001) Terminated |
HRS | K140876 |
| Jun 7, 2018 | Orthofix, Inc T-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-B-01001); b) Large (003-B-02001) Terminated |
HRS | K140876 |
| Jun 7, 2018 | Orthofix, Inc TN Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-F-01020); b) Medium (002-F-01025);
c) Large (002-F-01030) Terminated |
HRS | K140876 |
| Jun 7, 2018 | Orthofix, Inc Straight Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Holes (Part Number): a) 3 Hole (003-D-01001); b) 4 Hole (003-D-02001); c) 6 Hole (003-D-03001) Terminated |
HRS | K140876 |
| Jun 7, 2018 | Orthofix, Inc MTP Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-B-01001); b) Medium (002-B-02002);
c) Large (002-B-03003) Terminated |
HRS | K140876 |
| Jun 7, 2018 | Orthofix, Inc L-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Left or Right (Part Number): a) Left (003-E-00001L); b) Right (003-E-00001R) Terminated |
HRS | K140876 |
| Jun 7, 2018 | Orthofix, Inc Lapidus Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size/Step/Left or Right (Part Number):
a) Small/0MM Step/Left (002-C-01000L);
b) Small/0MM Step/Right (002-C-01000R);
c) Large/0MM St Terminated |
HRS | K140876 |
| Jun 7, 2018 | Orthofix, Inc H-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number):
a) 12MM Spacer (003-H-12001);
b) 15MM Spacer (003-H-15001);
20MM Spacer (003-H-20001);
25MM Spacer (003-H-25001);
3 Terminated |
HRS | K142135 |
| Jun 7, 2018 | Orthofix, Inc Evans Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 6MM Spacer (002-H-00006);
b) 8MM Spacer (022-H-00008);
c) 10MM Spacer (002-H-00010);
d) 12MM Spacer (002-H-0001 Terminated |
HRS | K140876 |
| Jun 7, 2018 | Orthofix, Inc CC Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-G-01020);
b) Medium (002-G-01025);
c) Large (002-G-01030) Terminated |
HRS | K140876 |
| Jun 7, 2018 | Orthofix, Inc Box Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 18MM (003-F-18001);
b) 22MM (003-F-22001);
c) 30MM (003-F-30001) Terminated |
HRS | K142135 |
| Jun 7, 2018 | Orthofix, Inc Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 3.2MM X 10MM (002-E-32010)
b) D 3.2MM X 12MM (002-E-32012)
c) D 3.2MM X 14MM (002-E-32014)
d) D 3.2MM X 16MM ( Terminated |
HRS | K140876 |
| Jun 7, 2018 | Orthofix, Inc Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a)D 3.2MM X 10MM (002-D-32010)
b) D 3.2MM X 12MM (002-D-32012)
c) D 3.2MM X 14MM (002-D-32014)
d) D 3.2MM X 16M Terminated |
HRS | K140876 |
| Jun 7, 2018 | Orthofix, Inc Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 2.7MM X 8MM (002-E-27008),
b) D 2.7MM X 10MM (002-E-27010);
c) D 2.7MM X 12MM (002-E-27012);
d) D 2.7MM X 14MM Terminated |
HRS | K140876 |
| Jun 7, 2018 | Orthofix, Inc Non-Locking Screw, D 2.7MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Numbers): a) D 2.7MM X 8MM (002-D-27008);
b) D 2.7MM X 10MM (002-D-27010);
c) D 2.7MM X 12MM (002-D-270 Terminated |
HRS | K140876 |
| Jun 7, 2018 | Orthofix, Inc Locking Screw, D 2.0MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM X 8MM (002-E-20008); b) D 2.0MM X 10MM (002-E-20010);
c) D 2.0MM X 12MM (002-E-20012);
Terminated |
HRS | K140876 |
| Jun 7, 2018 | Orthofix, Inc Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM X 8MM (0002-D-20008); b) D 2.0MM X 10MM (002-D-20010);
c) D 2.0MM X 12MM (002-D-20012);
d) D 2.0MM Terminated |
HRS | K140876 |
| Jun 7, 2018 | Orthofix, Inc Rival Reduce Kit Plates, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-012C Terminated |
HRS | K142135 |
| Jun 7, 2018 | Orthofix, Inc Rival View Kit Locking and Non-Locking Screw D 2.7MM, D 3.2MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-009C Terminated |
HRS | K142135 |
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