InterSpace Hip

FDA UDI

Class II (US FDA UDI)

by Tecres

Identity

Trade Name: InterSpace Hip FDA UDI
Generic Name: Orthopaedic cement spacer FDA UDI
Device Name: Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device is sterile and single-use. InterSpace Hip is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity 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 Hip 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: SPC0122 FDA UDI
Description: Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device is sterile and single-use. InterSpace Hip is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity 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 Hip 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: 28031497000620 FDA UDI
510(k) Number: K101356 FDA UDI
FDA Product Code: MBB FDA UDI
KWL FDA UDI
KWY FDA UDI
GMDN Term: Orthopaedic cement spacer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3027 FDA UDI
888.3360 FDA UDI
888.3390 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

Dimensions & Sizes

Size: Length — 94 Millimeter FDA UDI

Category: Orthopaedic cement spacer

InterSpace Hip 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 dfbff883-d876-4124-b304-a03ad1379077 35 fields · synced May 30, 2026