Apex Fixation Pins
FDA 510(k) K001886 · Howmedica Osteonics Corp.
510(k) numberK001886
Submission
- Device name
- Apex Fixation Pins
- Applicant
- Howmedica Osteonics Corp.
Rutherford, NJ, US - Received
- June 21, 2000
- Decision date
- July 12, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDW – Pin, Fixation, Threaded
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JDW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260073 | XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmJDW · Special | Biodynamik, Inc. | 02/10/2026SE |
| K250316 | Meduloc Intramedullary Fracture Fixation (IFF) SystemJDW · Traditional | Meduloc, LLC | 10/29/2025SE |
| K241357 | XT3 SystemJDW · Traditional | Biodynamik, Inc. | 01/22/2025SE |
| K223112 | MAVERICK Mini External Fixation SystemJDW · Traditional | Smith & Nephew, Inc. | 12/08/2022SE |
| K213874 | MAVERICK External Fixation SystemJDW · Traditional | Smith & Nephew, Inc. | 02/11/2022SE |
| K211508 | Steinmann Pins and Kirschner WiresJDW · Traditional | Stryker GmbH | 10/05/2021SE |
| K210784 | Extended HA Half PinsJDW · Special | Smith & Nephew, Inc. | 04/02/2021SE |
| K200933 | Syntec Non-Sterile Steinmann Pins SystemJDW · Special | Syntec Scientific Corporation | 05/05/2020SE |
| K191803 | Orthopedic Fixation PinJDW · Traditional | Tinavi (Anhui) Medical Technologies Co., Ltd. | 04/14/2020SE |
| K192768 | Temporary Fixation PinsJDW · Traditional | Eisertech, LLC | 12/26/2019SE |
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| K130895 | Reunion Rsa Shoulder SystemPHX · Traditional | 12/27/2013SE |
| K123604 | Abg III Monolithic Hip StemMAY · Traditional | 08/16/2013SE |
| K122015 | Distal Femoral Growing Prosthesis, Tibial Rotating Components, Bearing, Axis, Circlip…KRO · Traditional | 02/22/2013SE |
| K123166 | Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon…JWH · Traditional | 02/14/2013SE |
| K122853 | Novel Fit and Fill StemMEH · Traditional | 02/01/2013SE |
| K121315 | Stryker CMF Medpor Customized ImplantFWP · Traditional | 11/01/2012SE |
| K121308 | Hip SystemsLPH · Traditional | 07/30/2012SE |
| K120578 | Accolade II Hip StemJDI · Special | 03/29/2012SE |
Questions and answers
When was Apex Fixation Pins cleared by the FDA?
Apex Fixation Pins (K001886) received a 510(k) decision of Substantially Equivalent on July 12, 2000, 21 days after the submission was received.
What is the product code of K001886?
The FDA product code is JDW – Pin, Fixation, Threaded, a Class II (moderate risk) device regulated under 21 CFR 888.3040.