# K021357: Medpor Plus Orbital Volume Replacement Impant

- Pathway: 510(k) (Traditional)
- Applicant: Porex Surgical, Inc.
- Decided: Aug 5, 2002 after 98 days
- Product code: HPZ (Implant, Eye Sphere)
- Device class: 2
- Regulation: 21 CFR 886.3320
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 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) Orbital volume replacement implants currently cleared for marketing: named in the summary without a submission number
- (no number) Bioglass Synthetic Bone Graft Particulate: named in the summary without a submission number

## Most influential descendants
- K070130: Orbital Reconstructive Implant (2007), 1 descendant of its own
- K212741: Ezypor (2022), 0 descendants of its own
- K083342: Orbital Reconstructive Implant II (2009), 0 descendants of its own

## Recalls of this device
- Mar 20, 2012 · Not classified · Z-1435-2012: The MEDPOR PLUS SST EZ 22mm sphere implants are not within specification of 22mm +/- 8, therefore implant is not easily released from the syringe.

## Indications for use
MEDPOR Surgical Implants in block, sheet and preformed shapes are intended for augmentation or restoration in the craniofacial region.

Source page: https://510kreport.com/device/K021357
Methodology: https://510kreport.com/methodology