# K962468: Hedrocel Acetabular Restrictor

- Pathway: 510(k) (Traditional)
- Applicant: Implex Corp.
- Decided: Feb 3, 1997 after 223 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 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) Zimmer Cement Restrictor #4043-20: named in the summary without a submission number
- (no number) Howmedica Charnley Cement Restrictor: named in the summary without a submission number
- (no number) Motech Titanium Surgical Mesh: named in the summary without a submission number

## Most influential descendants
- K113296: ZMR Hip System  KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/Polymer (2012), 2 descendants of its own
- K200823: Zimmer, Inc. Hip Joint Prostheses MR Labeling I (2020), 1 descendant of its own
- K250834: Zimmer Biomet Ceramic Heads (22.2mm diameter) (2025), 0 descendants of its own
- K040756: The Trabecular Metal Reconstruction System, Model 10-340-Xxxxx (2004), 0 descendants of its own

## Indications for use
The Hedrocel® Acetabular Restrictor is a device intended for restriction of effusion of bone cement, allograft bone, and/or autograft bone into the pelvis if defects in-the acetabulum are encountered.

Source page: https://510kreport.com/device/K962468
Methodology: https://510kreport.com/methodology