Interspace Knee ATS 60/07
Basic Information
- Brand Name
- Interspace Knee ATS 60/07
- Primary DI
- 28031497001870
- Version / Model
- SPK0422
- Company Name
- TECRES SPA
- Labeler DUNS
- 435428396
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-14
- Public Version
- 1
- Public Version Date
- 2019-08-22
- Public Version Status
- New
- Public Device Record Key
- fef78278-a9e6-4552-997d-2b1425b7c3b3
Device Description
Temporary Augmented Tibial Stem Spacer with gentamicin. Interspace Knee ATS is composed of fully formed gentamicin/polymethylmethacrylate (PMMA), radio-opaque bone cement. The device is sterile and single-use. InterSpace Knee ATS is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process, and where a large tibial defect is present. InterSpace Knee ATS is applied on the tibial plate following removal of the existing implant and radical debridement. The device must be combined with the tibial component of InterSpace Knee. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Knee ATS 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), the Interspace Knee ATS is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | 888.3560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33982 | Orthopaedic cement spacer | A prefabricated device made of orthopaedic bone cement [e.g., polymethylmethacrylate (PMMA)], with an appropriate antibiotic, that is temporarily placed into a joint space to function as a carrier for the local delivery of antibiotic drugs and to prevent bone-on-bone contact and contraction of soft-tissue during surgical treatment of an infected joint. The shape and size of the device is modified to fit the joint space. This non-weight-bearing spacer remains in place until the infection clears; it is then removed and replaced with a conventional joint prosthesis. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 28031497001870 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181732 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Tibial insert width: 60 mm | ||
| Device Size Text, specify | Tibial Insert thickness: 07 mm | ||
| Device Size Text, specify | Tibial insert - stem length: 32 mm |