InterSpace Knee

FDA UDI

Class II (US FDA UDI)

by Tecres

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 of 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 implantand 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.). FDA UDI
Model / Reference: SPK0022 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 of 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 implantand 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.). FDA UDI

Identifiers

Primary DI / UDI-DI: 28031497000583 FDA UDI
510(k) Number: K101356 FDA UDI
FDA Product Code: JWH FDA UDI
MBB FDA UDI
GMDN Term: Orthopaedic cement spacer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3560 FDA UDI
888.3027 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

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

K101356 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 73d0611b-9974-471c-8283-f149fb796747 35 fields · synced May 30, 2026