Identity
- Trade Name
- iTotal® Hip Replacement System FDA UDI
- Generic Name
- Non-constrained polyethylene acetabular liner FDA UDI
- Device Name
- HIP-IPOLY XE-LINER-GRP D (54-57) 40MM LIP FDA UDI
- Model / Reference
- HDL060D32L01 FDA UDI
- Description
- HIP-IPOLY XE-LINER-GRP D (54-57) 40MM LIP FDA UDI
Identifiers
- Catalog Number
- HDL060D32L FDA UDI
- Primary DI / UDI-DI
- M572HDL060D32L011 FDA UDI
- 510(k) Number
- K162719 FDA UDI
- FDA Product Code
- OQG FDA UDIMEH FDA UDILZO FDA UDILPH FDA UDI
- GMDN Term
- Non-constrained polyethylene acetabular liner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 FDA UDI888.3353 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
No
Category: Non-constrained polyethylene acetabular liner
The iTotal Hip Replacement System is a non-constrained polyethylene acetabular liner designed for total hip arthroplasty (THA). This device features a porous uncemented design, making it an ideal option for patients with limited joint space or those requiring a more customized fit. The iTotal Hip Replacement System has received FDA clearance and is now available in the market.
Similar devices
Also classified as Non-constrained polyethylene acetabular liner.
- C-Fit & DC-Fit Acetabular Cup System — CORIN LTD · Class II
- RINGLOC HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
- MobileLink Acetabular Cup System — WALDEMAR LINK GmbH & Co. KG · Class II
- PRIME — MicroPort Orthopedics Inc. · Class II
- G7 Acetabular Liner — Biomet Orthopedics, Inc. · Class II
- Logical 20° Hooded Liner — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- RINGLOC RX90-2 HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
- PINNACLE — DEPUY ORTHOPAEDICS, INC. · Class II
Cleared under the same submission
K162719 also covers:
- iTotal® Hip Replacement System — Conformis, Inc.
- iTotal® Hip Replacement System — Conformis, Inc.
- iTotal® Hip Replacement System — Conformis, Inc.
- iTotal® Hip Replacement System — Conformis, Inc.
- iTotal® Hip Replacement System — Conformis, Inc.
- iTotal® Hip Replacement System — Conformis, Inc.
- iTotal® Hip Replacement System — Conformis, Inc.
- iTotal® Hip Replacement System — Conformis, Inc.
- iTotal® Hip Replacement System — Conformis, Inc.
- iTotal® Hip Replacement System — Conformis, Inc.
- iTotal® Hip Replacement System — Conformis, Inc.
- iTotal® Hip Replacement System — Conformis, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Conformis, Inc.
Sources (1)
- FDA UDI db56c912-2ea5-46c9-8642-7c8053e4d6f0 37 fields · synced Jul 17, 2026