510(k) · Cleared
Recalled · 2011Osteopore PCL Scaffold
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteopore, Inc. · GXP Methyl Methacrylate For Cranioplasty
Cleared on Mar 17, 2006 as substantially equivalent to K003015 (Surgical Specialties Corp, 2000) and 1 other predicate after a 323-day review. Its family tree reaches back 2 generations to 2002. 2 later devices descend from it. It has been recalled once.
- Decided
- Mar 17, 2006
- Review
- 323 days
- Class
- Class II
- Product code
- GXP
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K013966 (2002). 3 ancestors in all, the oldest K003015 (2000). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK013966 Apatight-TCP Bone Graft SubstituteCerabio, LLC · 2002
- 1 generation backK022629 WMT-TCP Bone Graft SubstituteWrightmedicaltechnologyinc · 2002
- This deviceK051093 Osteopore PCL ScaffoldOsteopore, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK251959 TnR Cranial ImplantT&R BIOFAB CO., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK123633 TRS Cranial Bone Void Filler (TRS C-BVF)Tissue Regeneration Systems, Inc. · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K013966 | Apatight-TCP Bone Graft Substitute | Cerabio, LLC | 2002 | — |
| −1 | K022629 | WMT-TCP Bone Graft Substitute | Wrightmedicaltechnologyinc | 2002 | — |
| 0 (this device) | K051093 | Osteopore PCL Scaffold | Osteopore, Inc. | 2006 | — |
| +1 | K251959 | TnR Cranial Implant | T&R BIOFAB CO., Ltd. | 2026 | — |
| +1 | K123633 | TRS Cranial Bone Void Filler (TRS C-BVF) | Tissue Regeneration Systems, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GXP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GXP device
- #1 K241027 Permatage Settable Bone Puttyscore 16.5 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K003015 | Ssc's PCL Monofilament Sas, Violet, Coated, Model TBDSummary page 1…ame: Bone Filler Classification Name: GXP Predicate Device/Material PCL Monofilament Surgical Specialties K003015 Absorbable Suture WMT-TCP… | 2000 |
| * | K022629 | WMT-TCP Bone Graft SubstituteSummary page 1…ies K003015 Absorbable Suture WMT-TCP K022629 ChronOS K013072… | 2002 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 27, 2011 | Not classified | Z-0446-2012 | Nonconforming Material/Component | Product sterility may be compromised. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K251959 (T&R BIOFAB CO., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K003015.
How does its category compare?
All GXP devicesGXP Methyl Methacrylate For Cranioplasty: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GXP
4so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · GXP
87in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXP
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXP
1in 2025
MAUDE reports naming product code GXP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 87 | 0 | 8 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 1 | — | 1 | 22 |
| 2010 | 1 | — | 0 | 59 |
| 2011 | 0 | — | 1 | 31 |
| 2012 | 0 | — | 1 | 28 |
| 2013 | 0 | — | 0 | 18 |
| 2014 | 0 | — | 0 | 19 |
| 2015 | 1 | — | 0 | 13 |
| 2016 | 0 | — | 0 | 17 |
| 2017 | 1 | — | 0 | 16 |
| 2018 | 0 | — | 0 | 9 |
| 2019 | 1 | — | 2 | 9 |
| 2020 | 0 | — | 0 | 31 |
| 2021 | 0 | — | 0 | 14 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 2 | — | 0 | 2 |
| 2024 | 2 | — | 0 | 10 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 4 | 85 | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051093 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051093: Osteopore PCL Scaffold.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051093
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026