# K974203: Perry-Kolberg (PK) Titanium Motility/Support System

- Pathway: 510(k) (Traditional)
- Applicant: Integrated Orbital Implants, Inc.
- Decided: Feb 4, 1998 after 86 days
- Product code: MQU (Ocular Peg)
- 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
Longest line of descent: 1 generation back to K954939 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971583: Medpor Ocular Screw and Acceossories, Porex Technologies Corp. (1997) Summary page 1.
- K960859: Medpor Ocular Peg System and Accessories, Porex Technologies Corp. of Georgia (1996) Summary page 3.
- K954939: Medpor Ocular Screw & Accessories, Porex Surgical, Inc. (1996) Summary page 3.

## Recalls of this device
- Dec 20, 2006 · Not classified · Z-0396-2007: The threads on the threaded sleeve were manufactured with left-handed threads, requiring a modification to the surgical technique for proper insertion. Failure to properly identify the affected compon

## Indications for use
The Perry-Kolberg Titanium Motility/Support System is intended to provide a direct mechanical coupling of an ocular prosthesis to an orbital implant (eye sphere implant) in order to enhance motility of the prosthesis over that of a prosthesis used without a direct coupling to the implant. It also reduces the weight of the ocular prosthesis on the lower eyelid. It may be placed in a secondary operation that occurs after the ocular implant has become vascularized, approximately three to six months after implant placement. Alternatively, it may be placed during the initial implantation procedure before closing the Tenon’s capsule and the conjunctiva.

Source page: https://510kreport.com/device/K974203
Methodology: https://510kreport.com/methodology