# K051093: Osteopore PCL Scaffold

- Pathway: 510(k) (Traditional)
- Applicant: Osteopore, Inc.
- Decided: Mar 17, 2006 after 323 days
- Product code: GXP (Methyl Methacrylate For Cranioplasty)
- Device class: 2
- Regulation: 21 CFR 882.5300
- 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: 2 generations back to K013966 (2002). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003015: Ssc's PCL Monofilament Sas, Violet, Coated, Model TBD, Surgical Specialties Corp (2000) Summary page 1.
- K022629: WMT-TCP Bone Graft Substitute, Wrightmedicaltechnologyinc (2002) Summary page 1.

## Most influential descendants
- K251959: TnR Cranial Implant (2026), 0 descendants of its own
- K123633: TRS Cranial Bone Void Filler (TRS C-BVF) (2013), 0 descendants of its own

## Recalls of this device
- Apr 27, 2011 · Not classified · Z-0446-2012: Product sterility may be compromised.

## Indications for use
The Osteopore PCL Scaffold Bone Filler is intended for the use in the repair of neurosurgical burr holes, craniotomy cuts and other cranial defects. It is also for use in the augmentation or restoration of bony contour in the craniofacial skeleton.

Source page: https://510kreport.com/device/K051093
Methodology: https://510kreport.com/methodology