APEX FIXATION PINS
FDA 510(k) clearance K001886 · decided 2000-07-12
Clearance details
- K-number
- K001886
- Device name
- APEX FIXATION PINS
- Applicant
- Howmedica Osteonics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2000-06-21
- Decision date
- 2000-07-12
- Days to decision
- 21 days
- Clearance type
- Special
- Product code
- JDW
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Rutherford, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
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| XT3 System (K241357) | Biodynamik, Inc. | 2025-01-22 |
| MAVERICK Mini External Fixation System (K223112) | Smith & Nephew, Inc. | 2022-12-08 |
| MAVERICK External Fixation System (K213874) | Smith & Nephew, Inc. | 2022-02-11 |
| Steinmann Pins and Kirschner Wires (K211508) | Stryker GmbH | 2021-10-05 |
| Extended HA Half Pins (K210784) | Smith & Nephew, Inc. | 2021-04-02 |
| Syntec Non-Sterile Steinmann Pins System (K200933) | Syntec Scientific Corporation | 2020-05-05 |
| Orthopedic Fixation Pin (K191803) | Tinavi (Anhui) Medical Technologies Co., Ltd. | 2020-04-14 |
| Temporary Fixation Pins (K192768) | Eisertech, LLC | 2019-12-26 |
| SMV Scientific K-Wire and Pins (K182171) | Summit Medventures | 2018-10-25 |
| Ultima HA Coated Half Pins and Wire (K163487) | Vilex IN Tennessee, Inc. | 2017-02-13 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Trident Alumina Insert (625-0T-XXX); Osteonics® ABC/Trident® System (P000013/S027) | Howmedica Osteonics Corp. | 2025-09-17 |
| Trident Acetabular System: Trident Alumina Inserts (P000013/S026) | Howmedica Osteonics Corp. | 2025-05-23 |
| Trident® Acetabular System (P000013/S025) | Howmedica Osteonics Corp. | 2024-03-08 |
| Trident(R), ABC(R) (P000013/S024) | Howmedica Osteonics Corp. | 2024-01-23 |
| Trident Ceramic System (P000013/S021) | Howmedica Osteonics Corp. | 2023-12-20 |
| Trident(R), ABC(R) (P000013/S023) | Howmedica Osteonics Corp. | 2023-12-19 |
| Trident®, ABC® (P000013/S022) | Howmedica Osteonics Corp. | 2023-09-27 |
| Trident Acetabular System: Trident Alumina Inserts (P000013/S020) | Howmedica Osteonics Corp. | 2022-04-01 |