Worrell Patella
FDA 510(k) K771708 · Depuy, Inc.
510(k) numberK771708
Submission
- Device name
- Worrell Patella
- Applicant
- Depuy, Inc.
Mchenry, IL, US - Received
- September 12, 1977
- Decision date
- October 6, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HTG – Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3580
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HTG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K800800 | Patellar Component for Lubinus PatellarHTG · Traditional | Waldemar Link GmbH & Co. KG | 04/21/1980SE |
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| K033329 | Depuy Ace Universal and Troch Entry Femoral Nail SystemsHSB · Traditional | 11/14/2003SE |
| K032151 | Depuy Sigma Tibial Inserts and Co-Cr Tibial TraysJWH · Special | 09/26/2003SE |
| K020541 | Agility Ankle Revision ProsthesisHSN · Traditional | 05/20/2002SE |
| K011810 | Orthogenesis LPS Proximal Tibial Replacement and Orthogenesis LPS Tibial BearingKRO · Traditional | 09/07/2001SE |
Questions and answers
When was Worrell Patella cleared by the FDA?
Worrell Patella (K771708) received a 510(k) decision of Substantially Equivalent on October 6, 1977, 24 days after the submission was received.
What is the product code of K771708?
The FDA product code is HTG – Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3580.