# K972393: Inter-OP HA Porous Acetabular System (HA/Csti)

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Orthopedics, Inc.
- Decided: Sep 19, 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.
312 later devices descend from it; 3 cite it directly.
0 of 313 devices 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) Inter-Op Porous Acetabular System: named in the summary without a submission number
- (no number) APR HA Porous Hip System: named in the summary without a submission number
- (no number) Natural-Hip HA: named in the summary without a submission number

## Most influential descendants
- K980711: Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating (1998), 309 descendants of its own
- K030733: Mayo Conservative Hip Prosthesis, Model 8026 Series (2003), 296 descendants of its own
- K040191: Bicontact Hip Stem and Femoral Head (2004), 267 descendants of its own
- K001277: Triflange Acetabular Cup System (2000), 213 descendants of its own
- K031495: Pinnacle Duofix HA Acetabular Cup Prosthesis (2003), 207 descendants of its own

## Indications for use
Components of the Inter-Op HA Porous Acetabular System are intended to replace the acetabulum during total hip arthroplasty. The four metallic shell styles are porous coated and used in conjunction with a snap-in polyethylene liner. The acetabular components of this system are intended to achieve biological fixation to bone without the use of bone cement. While three of the shell styles are hemispherical, the Protrusio HA Porous Shell is designed to compensate for protrusio defects where there has been thinning of the medial and superior walls of the acetabulum. The inner diameter is hemispherical while the outer shell has a 10mm build up, thus maintaining the anatomical hip center and avoiding the medialization of the femoral component. Diagnostic indications for use of components of the Inter-Op HA Porous Acetabular System 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/K972393
Methodology: https://510kreport.com/methodology