Ace/Kyle Captured Hip Screw
FDA 510(k) K813554 · Ace Orthopedic Manufacturing Co.
510(k) numberK813554
Submission
- Device name
- Ace/Kyle Captured Hip Screw
- Applicant
- Ace Orthopedic Manufacturing Co.
Walker, MI, US - Received
- December 22, 1981
- Decision date
- January 12, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KTT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254087 | MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction SystemKTT · Traditional | Synthes (USA) Products, LLC | 06/11/2026SE |
| K260900 | DYNEX® External Fixation SystemsKTT · Special | Vilex, LLC | 04/17/2026SE |
| K260112 | QuikFix External Fixator: Knee-Spanning PackKTT · Traditional | Stabiliz Orthopaedics, Inc. | 03/23/2026SE |
| K253291 | Excelsior SystemKTT · Traditional | Blue Ocean Global | 01/20/2026SE |
| K253613 | Monkey Rings External Ring Fixation SystemKTT · Special | Paragon 28, Inc. | 12/19/2025SE |
| K253202 | Hoffmann LRF SystemKTT · Traditional | Stryker GmbH | 12/19/2025SE |
| K252555 | Medusa Orthopedics Boa External Fixation SystemKTT · Traditional | Medusa Orthopedics, LLC | 11/25/2025SE |
| K252625 | The Response Ortho Smart Fixator - Hexapod SystemKTT · Traditional | Response Ortho Solutions, LLC | 11/20/2025SE |
| K252106 | External Fixation Mini Rail SystemKTT · Traditional | Paragon 28, Inc. | 09/30/2025SE |
| K251862 | External Fixation Bone DistractorKTT · Traditional | Paragon 28, Inc. | 08/11/2025SE |
More from Paragon 28, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K934962 | Aim Supracondylar NailHSB · Traditional | 03/22/1994SE |
| K934643 | Ace Humeral NailHSB · Traditional | 03/22/1994SE |
| K936045 | Ace Unilateral Fixator IIJEC · Traditional | 02/22/1994SE |
| K926047 | Ace 8.0MM Cannulated Cancellous Bone ScrewHWC · Traditional | 03/31/1993SE |
| K920738 | Ace 100 Degrees Tubular PlateHRS · Traditional | 07/27/1992SE |
| K810193 | Trippi-Wells Dual Purpose Universal TongHAX · Traditional | 03/20/1981SE |
| K801594 | Ace Fischer External Fixation DeviceHXK · Traditional | 09/09/1980SE |
| K791466 | Ace External Bone Clamp Part #S11JEC · Traditional | 08/16/1979SE |
| K781841 | Bar, DistractionJEC · Traditional | 11/08/1978SE |
| K781840 | External ArticulationJEC · Traditional | 11/08/1978SE |
Questions and answers
When was Ace/Kyle Captured Hip Screw cleared by the FDA?
Ace/Kyle Captured Hip Screw (K813554) received a 510(k) decision of Substantially Equivalent on January 12, 1982, 21 days after the submission was received.
What is the product code of K813554?
The FDA product code is KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, a Class II (moderate risk) device regulated under 21 CFR 888.3030.