# K970705: Inter-OP Porous Revision Shell with Sealable Screwholes

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Orthopedics, Inc.
- Decided: May 22, 1997 after 85 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) APR Acetabular Shell: named in the summary without a submission number
- (no number) S-ROM ZTT II Acetabular Shell with Apical Hole Plug: named in the summary without a submission number
- (no number) P.F.C. Multi-Holed Porous Coated Acetabular Shell: named in the summary without a submission number
- (no number) Duraloc 1200 Series Acetabular Cup: named in the summary without a submission number
- (no number) Trilogy Multi-Holed Shell: named in the summary without a submission number

## Indications for use
The Inter-Op Porous Revision Shell with Sealable Screwholes is a porous coated hemispherical shell that is used in conjunction with a snap-in acetabular insert manufactured from ultra-high molecular weight polyethylene (UHMWPE). This device is intended to replace the acétabulum during total hip arthroplasty and may be implanted with or without bone cement. Diagnostic indications for use. of this device include: revision of a previously implanted acetabular prosthesis; patient conditions of noninflammatory degenerative joint disease; e.g., avascular necrosis, osteoarthritis, or arthritis secondary to a variety of diseases and anomalies; and, inflammatory joint disease; e.g., rheumatoid arthritis.

Source page: https://510kreport.com/device/K970705
Methodology: https://510kreport.com/methodology