InterSpace Knee Extra-Large Size, InterSpace Knee ATS
FDA 510(k) K181732 · Tecres S.P.A.
510(k) numberK181732
Submission
- Device name
- InterSpace Knee Extra-Large Size, InterSpace Knee ATS
- Applicant
- Tecres S.P.A.
Sommacampagna, IT - Received
- July 2, 2018
- Decision date
- April 27, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3560
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JWH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260063 | GSPE SpacerJWH · Traditional | The General Hospital Corporation, d/b/a… | 09/11/2026SE |
| K262293 | EVOLUTION MPX Total Knee SystemJWH · Traditional | Suzhou Microport Orthorecon Co., Ltd. | 09/10/2026SE |
| K262341 | b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and…JWH · Traditional | B-One Ortho, Corp. | 09/08/2026SE |
| K262130 | ATTUNE Revision Knee SystemJWH · Traditional | Depuy Orthopaedics, Inc. | 09/04/2026SE |
| K253961 | SK Knee SystemJWH · Traditional | Just Medical Devices (Tianjin) Co., Ltd. | 09/01/2026SE |
| K261563 | Freedom Total Knee System (E-Poly Tibial Liners)JWH · Traditional | Maxx Orthopedics, Inc. | 08/07/2026SE |
| K262251 | ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)JWH · Special | Globus Medical, Inc. | 07/31/2026SE |
| K261734 | Klassic Infection Spacer SystemJWH · Traditional | Total Joint Orthopedics, Inc. | 07/23/2026SE |
| K261458 | ATTUNE Total Knee System; ATTUNE Cementless Knee SystemJWH · Traditional | DePuy Ireland UC | 06/25/2026SE |
| K261032 | NovoKnee (SteriKnee)JWH · Special | NovoSource | 04/27/2026SE |
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| K252326 | InterSpace GV Hip SpacerKWL · Special | 08/06/2025SE |
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| K220131 | KYPHON VuE Bone CementNDN · Traditional | 04/18/2022SE |
| K122175 | Mendec Spine HV, Mendec Spine HV SystemNDN · Traditional | 03/28/2013SE |
| K112983 | Spacer-SHSD · Traditional | 12/12/2011SE |
| K101356 | Spacer-G and Spacer-KKWL · Traditional | 09/20/2011SE |
| K092773 | Cemex Genta, Genta System and Genta System FastLOD · Special | 11/24/2009SE |
| K062274 | Spacer-K Temporary Knee Spacer with Gentamicin, Models SPK0021, SPK0121, SPK0221, SPK0321JWH · Traditional | 05/22/2008SE |
| K062273 | Spacer-G Temporary Hip ProsthesisKWL · Traditional | 05/22/2008SE |
| K063438 | VspspnNDN · Traditional | 01/17/2007SE |
Questions and answers
When was InterSpace Knee Extra-Large Size, InterSpace Knee ATS cleared by the FDA?
InterSpace Knee Extra-Large Size, InterSpace Knee ATS (K181732) received a 510(k) decision of Substantially Equivalent on April 27, 2019, 299 days after the submission was received.
What is the product code of K181732?
The FDA product code is JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3560.