Identity
- Trade Name
- InterSpace Knee FDA UDI
- Generic Name
- Orthopaedic cement spacer FDA UDI
- Device Name
- Temporary knee spacer with gentamicin. InterSpace Knee is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement. The device is sterile and single-use. InterSpace Knee is indicated for temporary use (maximum 180 days) as a total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. InterSpace Knee is applied on the femoral condyles and on the tibial plate following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Knee is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.). Because of the inherent mechanical limitations of the device material (gentamicin/polymethylmethacrylate), Interspace Knee is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period. FDA UDI
- Model / Reference
- SPK0322 FDA UDI
- Description
- Temporary knee spacer with gentamicin. InterSpace Knee is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement. The device is sterile and single-use. InterSpace Knee is indicated for temporary use (maximum 180 days) as a total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. InterSpace Knee is applied on the femoral condyles and on the tibial plate following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Knee is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.). Because of the inherent mechanical limitations of the device material (gentamicin/polymethylmethacrylate), Interspace Knee is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 28031497001160 FDA UDI
- 510(k) Number
- K181732 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Orthopaedic cement spacer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic cement spacer
InterSpace Knee by Tecres — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K181732 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Tecres
Sources (1)
- FDA UDI dd5d4a66-41b2-4231-9fbd-b45a6dfedb4f 35 fields · synced Jun 6, 2026