REDAPT Modular Acetabular Shell
510(k) K182109
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK182109 | Date16 Nov 2018 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LPH
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3358
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The REDAPT Modular Acetabular Shell is a modular acetabular component designed for use in revision total hip arthroplasty. It features a porous structure intended to facilitate bone ingrowth, mimicking cancellous bone to enhance fixation in cases with compromised acetabular bone. The modular design allows for the attachment of snap-in liners, providing versatility in addressing varying clinical needs during revision surgery. This device is classified as a revision acetabular shell under orthopedic nomenclature standards.
The REDAPT Modular Acetabular Shell is supplied as a reusable medical device and is intended for use in operating room settings. It is not described as sterile in the provided data, though clinical practice may require sterilization prior to use. The device is available in configurations compatible with snap-in liner systems, with dimensions and sizing determined by the manufacturer’s specifications. Its regulatory status includes FDA clearance under a 510(k) submission, classified under the Orthopedic Advisory Committee and product code LPH.