Product code HWT
- Device name
- Template
- Medical specialty
- Orthopedic
- Device class
- 1
- Regulation number
- 888.4800
- Review panel
- OR
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K974406 | ORTHOPLAN | Ortho-Graphics, Inc. | 1998-02-18 |
| K960685 | ORTHODOC PREOPERATIVE PLANNER MODEL 500 | Integrated Surgical Systems, Inc. | 1997-01-17 |
| K894228 | KRONNER SPHERICAL CUTTERS | Kronner Medical | 1990-07-23 |
| K870843 | SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA | Warsaw Orthopedic, Inc. | 1987-05-27 |
| K871323 | ARTHROSCOPIC MENISCAL SUTURE SYSTEM | Orthopedic Systems, Inc. | 1987-05-01 |
| K830360 | 3M OSTEOTOMY GUIDE | 3M Company | 1983-03-01 |
| K811205 | MOLDED POLYSULFONE TRIAL PROSTHESIS | Shannon Group | 1981-05-21 |
| K781091 | KNEE INSTRUMENTATION, CONDYLAR | Biomet, Inc. | 1978-07-17 |
| K771709 | WORRELL TRIAL PATELLA | Depuy, Inc. | 1977-10-06 |
| K771710 | WORRELL PATELLA TEMPLATE | Depuy, Inc. | 1977-10-06 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04260056886058 | InterSpace® Hip Mold Trial Head 56 mm | OSARTIS GmbH | 2026-10-29 |
| 04260056886423 | InterSpace® Knee Mold Trial Tibial Stemmed Insert | OSARTIS GmbH | 2026-10-29 |
| 04260056886416 | InterSpace® Knee Mold Trial Tibial Insert | OSARTIS GmbH | 2026-10-29 |
| 04260056886287 | InterSpace® Knee Mold Trial Tibial Stem | OSARTIS GmbH | 2026-10-29 |
| 04260056886270 | InterSpace® Knee Mold Trial Tibial Component XL | OSARTIS GmbH | 2026-10-29 |
| 04260056886256 | InterSpace® Knee Mold Trial Tibial Component L | OSARTIS GmbH | 2026-10-29 |
| 04260056886232 | InterSpace® Knee Mold Trial Tibial Component M | OSARTIS GmbH | 2026-10-29 |
| 04260056886218 | InterSpace® Knee Mold Trial Tibial Component S | OSARTIS GmbH | 2026-10-29 |
| 04260056886195 | InterSpace® Knee Mold Trial Tibial Component XS | OSARTIS GmbH | 2026-10-29 |
| 04260056886171 | InterSpace® Knee Mold Trial Femoral Component XL | OSARTIS GmbH | 2026-10-29 |
| 04260056886157 | InterSpace® Knee Mold Trial Femoral Component L | OSARTIS GmbH | 2026-10-29 |
| 04260056886133 | InterSpace® Knee Mold Trial Femoral Component M | OSARTIS GmbH | 2026-10-29 |
| 04260056886119 | InterSpace® Knee Mold Trial Femoral Component S | OSARTIS GmbH | 2026-10-29 |
| 04260056886096 | InterSpace® Knee Mold Trial Femoral Component XS | OSARTIS GmbH | 2026-10-29 |
| 04260056886072 | InterSpace® Hip Mold Trial Head 60 mm | OSARTIS GmbH | 2026-10-29 |
| 04260056886034 | InterSpace® Hip Mold Trial Head 52 mm | OSARTIS GmbH | 2026-10-29 |
| 04260056886010 | InterSpace® Hip Mold Trial Head 48 mm | OSARTIS GmbH | 2026-10-29 |
| 04260056885990 | InterSpace® Hip Mold Trial Head 42 mm | OSARTIS GmbH | 2026-10-29 |
| 04260056885976 | InterSpace® Hip Mold Trial Long Stem | OSARTIS GmbH | 2026-10-29 |
| 04260056885952 | InterSpace® Hip Mold Trial Long Stem | OSARTIS GmbH | 2026-10-29 |
| 04260056885938 | InterSpace® Hip Mold Trial Long Stem | OSARTIS GmbH | 2026-10-29 |
| 04260056885914 | InterSpace® Hip Mold Trial Short Stem | OSARTIS GmbH | 2026-10-29 |
| 04260056885891 | InterSpace® Hip Mold Trial Short Stem | OSARTIS GmbH | 2026-10-29 |
| 04260056885877 | InterSpace® Hip Mold Trial Short Stem | OSARTIS GmbH | 2026-10-29 |
| 00190446266204 | DJO SURGICAL | Encore Medical, L.P. | 2018-09-07 |
| 00190446266259 | DJO SURGICAL | Encore Medical, L.P. | 2018-09-07 |
| 00190446266242 | DJO SURGICAL | Encore Medical, L.P. | 2018-09-07 |
| 00190446266235 | DJO SURGICAL | Encore Medical, L.P. | 2018-09-07 |
| 00190446266228 | DJO SURGICAL | Encore Medical, L.P. | 2018-09-07 |
| 00190446266211 | DJO SURGICAL | Encore Medical, L.P. | 2018-09-07 |