Spacer-G and Spacer-K
FDA 510(k) K101356 · Tecres S.P.A.
510(k) numberK101356
Submission
- Device name
- Spacer-G and Spacer-K
- Applicant
- Tecres S.P.A.
Rockville, MD, US - Received
- May 14, 2010
- Decision date
- September 20, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWL – Prosthesis, Hip, Hemi-, Femoral, Metal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3360
- Specialty
- Orthopedic
- Implant
- Yes
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| K262290 | REMEDY POLY+PLUS SNAP FIT Acetabular CupKWL · Special | Osteoremedies, LLC | 07/24/2026SE |
| K260536 | Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone CementKWL · Traditional | Depuy Ireland UC | 05/15/2026SE |
| K253675 | OsteoRemedies Hip Spacer SystemKWL · Special | Osteoremedies, LLC | 12/23/2025SE |
| K252326 | InterSpace GV Hip SpacerKWL · Special | Tecres S.P.A. | 08/06/2025SE |
| K242865 | Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder SpacerKWL · Traditional | Biocomposites, Ltd. | 06/12/2025SE |
| K234028 | COPAL® exchange G hip spacer; COPAL® G+VKWL · Traditional | Heraeus Medical GmbH | 02/15/2024SE |
| K222632 | UHR Bipolar Implants, Restoration GAP II ImplantsKWL · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 10/21/2022SE |
| K192995 | OsteoRemedies Hip Spacer SystemKWL · Special | Osteoremedies, LLC | 01/10/2020SE |
| K191981 | REMEDY Acetabular CupKWL · Special | Osteoremedies, LLC | 08/23/2019SE |
| K172906 | REMEDY PLUS Hip Spacer, UNITE PLUS Bone CementKWL · Traditional | Osteoremedies, LLC | 08/29/2018SE |
More from Osteoremedies, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K252326 | InterSpace GV Hip SpacerKWL · Special | 08/06/2025SE |
| K211163 | Bone Cement Genta, Bone Cement HV, Bone Cement LVLOD · Traditional | 01/09/2023SE |
| K220131 | KYPHON VuE Bone CementNDN · Traditional | 04/18/2022SE |
| K181732 | InterSpace Knee Extra-Large Size, InterSpace Knee ATSJWH · Traditional | 04/27/2019SE |
| K122175 | Mendec Spine HV, Mendec Spine HV SystemNDN · Traditional | 03/28/2013SE |
| K112983 | Spacer-SHSD · Traditional | 12/12/2011SE |
| 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 Spacer-G and Spacer-K cleared by the FDA?
Spacer-G and Spacer-K (K101356) received a 510(k) decision of Substantially Equivalent on September 20, 2011, 494 days after the submission was received.
What is the product code of K101356?
The FDA product code is KWL – Prosthesis, Hip, Hemi-, Femoral, Metal, a Class II (moderate risk) device regulated under 21 CFR 888.3360.