Panels › Orthopedic › Product code HWT · Class 1
Template
Regulation 888.4800
0510(k)s in 12 months (10 all time)
0recalls in 12 months (85 all time)
21recalls that name a 510(k)
Top companies in HWT
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer Inc. | 0 | 46 |
| Waldemar Link GmbH & Co. KG (Corp. Hq.) | 0 | 21 |
| Biomet, Inc. | 1 | 4 |
| Stryker Howmedica Osteonics Corp. | 0 | 4 |
| DePuy Orthopaedics, Inc. | 0 | 3 |
| Aesculap Implant Systems LLC | 0 | 2 |
| Depuy, Inc. | 2 | 0 |
| 3M Company | 1 | 0 |
| Biomet Microfixation, LLC | 0 | 1 |
| Encore Medical, Lp | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 25, 2024 | LINK BIO CORP LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00 Open, Classified |
HWT | None listed |
| Jul 13, 2022 | Materialise USA LLC ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear
Identification number SD900.208 Completed |
HWT | None listed |
| Jun 29, 2022 | DePuy Orthopaedics, Inc. ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant
Part Number: 254400525 Open, Classified |
HWT | None listed |
| Apr 20, 2018 | Integra LifeSciences Corp. The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the following labeling:
Catalog Number Product Description
TRL092002506 Humeral Stem Trial, 6mm
TRL092002507 Hu Terminated |
HWT | None listed |
| Feb 12, 2018 | Aesculap Implant Systems LLC NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST0468)
The affected part is provided in the Vega Knee System Set #ST0468. The Vega Knee System is used Terminated |
HWT | None listed |
| Apr 11, 2017 | Biomet Microfixation, LLC Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600 Terminated |
HWT | None listed |
| Jul 27, 2015 | Encore Medical, Lp FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139 Terminated |
HWT | None listed |
| Jul 14, 2015 | Biomet, Inc. Oxford Femoral Drill Guide Lateral IM Adapter
Product Usage:
Drill guide. The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing t Terminated |
HWT | None listed |
| Oct 16, 2014 | Biomet, Inc. Discovery Elbow Humeral Trial
Product Usage:
Biomet manufactures a variety of elbow joint replacement prostheses intended for primary and revision joint arthoplasty for use in cemented applications. Terminated |
HWT | None listed |
| Apr 9, 2014 | DePuy Orthopaedics, Inc. GLOBAL Anchor Peg Glenoid Plus
(APG+) 2.5MM Breakaway Guide Pin
Part # 2230-00-019, Non-Sterile, DePuy, Johnson & Johnson
Product Usage: Usage:
The GLOBAL APG+ 2.5mm Guide Pin is a single-use instru Terminated |
HWT | None listed |
| Dec 6, 2013 | Zimmer, Inc. NexGen Complete Knee Solution
CR Articular Surface Provisional-Striped Green 9mm Height Nonsterile
Devices are used in total knee arthroplasty and indicated for patients with severe pain and disabili Terminated |
HWT | None listed |
| Dec 6, 2013 | Zimmer, Inc. NexGen Complete Knee Solution
CR Articular Surface Provisional-Yellow 9mm Height Nonsterile
Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due Terminated |
HWT | None listed |
| Dec 6, 2013 | Zimmer, Inc. NexGen Complete Knee Solution
CR Articular Surface Provisional-Purple 9mm Height
Nonsterile
Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due Terminated |
HWT | None listed |
| Aug 26, 2013 | Waldemar Link GmbH & Co. KG (Corp. Hq.) TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/25, Stem size S-6, prox. Stem dia. 25 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Terminated |
HWT | K955296 |
| Aug 26, 2013 | Waldemar Link GmbH & Co. KG (Corp. Hq.) TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/22, Stem size S-5, prox. Stem dia. 22.5 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Terminated |
HWT | K955296 |
| Aug 26, 2013 | Waldemar Link GmbH & Co. KG (Corp. Hq.) TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/20, Stem size S-4, prox. Stem dia. 20 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Terminated |
HWT | K955296 |
| Aug 26, 2013 | Waldemar Link GmbH & Co. KG (Corp. Hq.) TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/18, Stem size S-3, prox. Stem dia. 18 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Terminated |
HWT | K955296 |
| Aug 26, 2013 | Waldemar Link GmbH & Co. KG (Corp. Hq.) TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/16, Stem size S-2, prox. Stem dia. 16 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Terminated |
HWT | K955296 |
| Aug 26, 2013 | Waldemar Link GmbH & Co. KG (Corp. Hq.) TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/14, Stem size S-1, prox. Stem dia. 14 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Terminated |
HWT | K955296 |
| Aug 26, 2013 | Waldemar Link GmbH & Co. KG (Corp. Hq.) TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/12, Stem size S-0, prox. Stem dia. 12 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Terminated |
HWT | K955296 |
| Aug 26, 2013 | Waldemar Link GmbH & Co. KG (Corp. Hq.) TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/25, Stem size 06, prox. Stem dia. 25 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Terminated |
HWT | K955296 |
| Aug 26, 2013 | Waldemar Link GmbH & Co. KG (Corp. Hq.) TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/22, Stem size 05, prox. Stem dia. 22.5 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Terminated |
HWT | K955296 |
| Aug 26, 2013 | Waldemar Link GmbH & Co. KG (Corp. Hq.) TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/20, Stem size 04, prox. Stem dia. 20 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Terminated |
HWT | K955296 |
| Aug 26, 2013 | Waldemar Link GmbH & Co. KG (Corp. Hq.) TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/18, Stem size 03, prox. Stem dia. 18 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Terminated |
HWT | K955296 |
| Aug 26, 2013 | Waldemar Link GmbH & Co. KG (Corp. Hq.) TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/16, Stem size 02, prox. Stem dia. 16 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Terminated |
HWT | K955296 |
| Aug 26, 2013 | Waldemar Link GmbH & Co. KG (Corp. Hq.) TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/14, Stem size 01, prox. Stem dia. 14 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Terminated |
HWT | K955296 |
| Aug 26, 2013 | Waldemar Link GmbH & Co. KG (Corp. Hq.) TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/12, Stem size 0, prox. Stem dia. 12 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Terminated |
HWT | K955296 |
| Aug 26, 2013 | Waldemar Link GmbH & Co. KG (Corp. Hq.) TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/25, Stem size 006, prox. Stem dia. 25 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Terminated |
HWT | K955296 |
| Aug 26, 2013 | Waldemar Link GmbH & Co. KG (Corp. Hq.) TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/22, Stem size 005, prox. Stem dia. 22.5 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Terminated |
HWT | K955296 |
| Aug 26, 2013 | Waldemar Link GmbH & Co. KG (Corp. Hq.) TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/20, Stem size 004, prox. Stem dia. 20 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Terminated |
HWT | K955296 |
| Aug 26, 2013 | Waldemar Link GmbH & Co. KG (Corp. Hq.) TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/18, Stem size 003, prox. Stem dia. 18 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Terminated |
HWT | K955296 |
| Aug 26, 2013 | Waldemar Link GmbH & Co. KG (Corp. Hq.) TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/16, Stem size 002, prox. Stem dia. 16 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Terminated |
HWT | K955296 |
| Aug 26, 2013 | Waldemar Link GmbH & Co. KG (Corp. Hq.) TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/14, Stem size 001, prox. Stem dia. 14 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Terminated |
HWT | K955296 |
| Aug 26, 2013 | Waldemar Link GmbH & Co. KG (Corp. Hq.) TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/12, Stem size 00, prox. Stem dia. 12 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Terminated |
HWT | K955296 |
| Jun 7, 2013 | DePuy Orthopaedics, Inc. DePuy Glenosphere orientation guide
Product Usage: The glenosphere orientation guide is an instrument used in reverse shoulder arthroplasty. The orientation guide is used to properly align the gl Terminated |
HWT | None listed |
| Nov 19, 2012 | Zimmer, Inc. 00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36
00780304002 MIS 12/14 Slotted Femoral Head Provisional +0X36
00780304003 MIS 12/14 Slotted Femoral Head Provisional +3.5X36
00780304004 M Terminated |
HWT | None listed |
| Nov 19, 2012 | Zimmer, Inc. 00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36
00780303602 MIS 12/14 Slotted Femoral Head Provisional +0X36
00780303603 MIS 12/14 Slotted Femoral Head Provisional +3.5X36
00780303604 M Terminated |
HWT | None listed |
| Nov 19, 2012 | Zimmer, Inc. 00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32
00780303202 MIS 12/14 Slotted Femoral Head Provisional +0X32
00780303203 MIS 12/14 Slotted Femoral Head Provisional +3.5X32
00780303204 M Terminated |
HWT | None listed |
| Nov 19, 2012 | Zimmer, Inc. 00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28
00780302802 MIS 12/14 Slotted Femoral Head Provisional +0X28
00780302803 MIS 12/14 Slotted Femoral Head Provisional +3.5X28
00780302804 M Terminated |
HWT | None listed |
| Nov 19, 2012 | Zimmer, Inc. 00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26
00780302602 MIS 12/14 Slotted Femoral Head Provisional +0X26
00780302603 MIS 12/14 Slotted Femoral Head Provisional +3.5X26
00780302604 M Terminated |
HWT | None listed |
| Nov 19, 2012 | Zimmer, Inc. 00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22
00780302202 MIS 12/14 Slotted Femoral Head Provisional +0X22
00780302203 MIS 12/14 Slotted Femoral Head Provisional +3.5X22
The provisiona Terminated |
HWT | None listed |
| Nov 19, 2012 | Zimmer, Inc. 00789504001 VerSys Femoral Head Provisional 40mm -3.5
00789504002 VerSys Femoral Head Provisional 40mm +0
00789504003 VerSys Femoral Head Provisional 40mm +3.5
00789504004 VerSys Femoral Head Provisio Terminated |
HWT | None listed |
| Nov 19, 2012 | Zimmer, Inc. . 00789503601 VerSys Femoral Head Provisional 36mm -3.5
00789503602 VerSys Femoral Head Provisional 36mm +0
00789503603 VerSys Femoral Head Provisional 36mm +3.5
00789503604 VerSys Femoral Head Provis Terminated |
HWT | None listed |
| Nov 19, 2012 | Zimmer, Inc. 00789503201 VerSys Femoral Head Provisional 32mm -3.5
00789503202 VerSys Femoral Head Provisional 32mm +0
00789503203 VerSys Femoral Head Provisional 32mm +3.5
00789503204 VerSys Femoral Head Provisio Terminated |
HWT | None listed |
| Nov 19, 2012 | Zimmer, Inc. . 00789502801 VerSys Femoral Head Provisional 28mm -3.5
00789502802 VerSys Femoral Head Provisional 28mm +0
00789502803 VerSys Femoral Head Provisional 28mm +3.5
00789502804 VerSys Femoral Head Provis Terminated |
HWT | None listed |
| Nov 19, 2012 | Zimmer, Inc. 00789502601 VerSys Femoral Head Provisional 26mm -3.5
00789502602 VerSys Femoral Head Provisional 26mm +0
00789502603 VerSys Femoral Head Provisional 26mm +3.5
00789502604 VerSys Femoral Head Provisio Terminated |
HWT | None listed |
| Nov 19, 2012 | Zimmer, Inc. Product 100789502202 VerSys Femoral Head Provisional 22mm +0
00789502203 VerSys Femoral Head Provisional 22mm +3.5
00789502220 VerSys Femoral Head Provisional 22mm -2
00789502230 VerSys Femoral Head P Terminated |
HWT | None listed |
| Sep 28, 2012 | Zimmer, Inc. 00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36
00780304002 MIS 12/14 Slotted Femoral Head Provisional +0X36
00780304003 MIS 12/14 Slotted Femoral Head Provisional +3.5X36
00780304004 M Terminated |
HWT | None listed |
| Sep 28, 2012 | Zimmer, Inc. 00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36
00780303602 MIS 12/14 Slotted Femoral Head Provisional +0X36
00780303603 MIS 12/14 Slotted Femoral Head Provisional +3.5X36
00780303604 M Terminated |
HWT | None listed |
| Sep 28, 2012 | Zimmer, Inc. 00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32
00780303202 MIS 12/14 Slotted Femoral Head Provisional +0X32
00780303203 MIS 12/14 Slotted Femoral Head Provisional +3.5X32
00780303204 M Terminated |
HWT | None listed |
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