Univation
FDA 510(k) K131167 · Aesculap Implant Systems, LLC
510(k) numberK131167
Submission
- Device name
- Univation
- Applicant
- Aesculap Implant Systems, LLC
Center Valley, PA, US - Received
- April 24, 2013
- Decision date
- October 17, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HRY – Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3530
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HRY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K193549 | SIGMA High Performance (HP) Partial Knee SystemHRY · Traditional | Depuy Ireland UC | 04/16/2020SE |
| K190633 | NanoOrtho NanoKnee® SystemHRY · Traditional | Nanoortho, LLC | 12/20/2019SE |
| K152631 | MPO Total Knee Systems MR LabelingHRY · Traditional | Microport Orthopedics, Inc. | 03/23/2016SE |
| K150410 | Restoris Porous Partial Knee SystemHRY · Special | Mako Surgical Corporation | 03/20/2015SE |
| K133940 | Oxford Fixed Lateral Bearing Partial Knee Replacement (Bearings / Trays)HRY · Traditional | Biomet UK, Ltd. | 03/28/2014SE |
| K122277 | Oxford Fixed Lateral Bearing Partial Knee Replacement (Oxford Tibial Trays A-F) Ixford…HRY · Traditional | Biomet Manufacturing Corp | 10/22/2012SE |
| K110415 | Signature Planner / Signature GuidesHRY · Traditional | Materialise NV | 05/16/2011SE |
| K100973 | Evolution Unicondylar Knee SystemHRY · Traditional | Wrightmedicaltechnologyinc | 08/10/2010SE |
| K082567 | Stryker Compartmental Knee System Line ExtensionHRY · Special | Howmedica Osteonics Corp. | 10/03/2008SE |
| K081293 | Univation Unicondylar Knee SystemHRY · Traditional | Aesculap Implant Systems, Inc. | 09/22/2008SE |
More from Aesculap Implant Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K213871 | Ennovate Cervical Spinal and Occiput SystemNKG · Traditional | 07/01/2022SE |
| K210963 | ENNOVATE Spinal SystemNKB · Traditional | 07/19/2021SE |
| K180433 | Ennovate®NKB · Traditional | 04/26/2018SE |
| K162134 | ENNOVATE Spinal SystemNKB · Traditional | 12/14/2016SE |
| K153700 | Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsOLO · Traditional | 07/08/2016SE |
| K153629 | ArcadiusXP C Spinal SystemOVE · Traditional | 05/25/2016SE |
| K153396 | Aesculap OrthoPilot Next GenerationOLO · Traditional | 05/16/2016SE |
| K151938 | S4 Cervical Spinal and Occiput SystemsNKG · Traditional | 10/21/2015SE |
| K151056 | Aesculap T-Space PEEK and XP Spinal SystemMAX · Traditional | 08/13/2015SE |
| K150544 | Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee SystemJWH · Special | 05/29/2015SE |
Questions and answers
When was Univation cleared by the FDA?
Univation (K131167) received a 510(k) decision of Substantially Equivalent on October 17, 2013, 176 days after the submission was received.
What is the product code of K131167?
The FDA product code is HRY – Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3530.