Orion Blade Plate for Tibial Osteotomy
FDA 510(k) K901272 · Med-Tek Corp.
510(k) numberK901272
Submission
- Device name
- Orion Blade Plate for Tibial Osteotomy
- Applicant
- Med-Tek Corp.
Indianapolis, IN, US - Received
- March 19, 1990
- Decision date
- April 23, 1990
- 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 |
|---|---|---|
| K903234 | F-19 Total Hip ProsthesisJDI · Traditional | 10/10/1990SE |
| K901687 | F-24 Femoral Hip ProsthesisLWJ · Traditional | 09/07/1990SE |
| K901451 | F-20 Cemented Metal-Backed Acetabular CupJDI · Traditional | 08/31/1990SN |
| K900428 | Anesthesia Breathing CircuitsCAI · Traditional | 08/17/1990SE |
| K901626 | H.N. Metal Backed Acetabular Cup, NoncementedKWA · Traditional | 08/14/1990SE |
| K901594 | H.N. Total Hip ProsthesisLWJ · Traditional | 08/03/1990SE |
| K901480 | F-20 Total Hip ProsthesisJDI · Traditional | 06/12/1990SE |
| K901273 | L.M.S. Self-Detachable Broach with StopHTY · Traditional | 06/05/1990SE |
| K901240 | Astel Non-Metal Backed Acetabular Cup for CementedJDI · Traditional | 03/26/1990SE |
| K894978 | Bacterial FilterCAH · Traditional | 11/02/1989SE |
Questions and answers
When was Orion Blade Plate for Tibial Osteotomy cleared by the FDA?
Orion Blade Plate for Tibial Osteotomy (K901272) received a 510(k) decision of Substantially Equivalent on April 23, 1990, 35 days after the submission was received.
What is the product code of K901272?
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.