510(k) · Cleared
ClearedOsteoFab Patient Specific Facial Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oxford Performance Materials, Inc. · KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Cleared on Jul 20, 2016 as substantially equivalent to K133809 (Oxford Performance Materials, 2014) after a 97-day review. Its family tree reaches back 7 generations to 1979.
- Decided
- Jul 20, 2016
- Review
- 97 days
- Class
- Class II
- Product code
- KKY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K791495 (1979). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK791495 Lukens Bone Wax (Gamma Radiation)Lukens Corp. · 1979
- 6 generations backK971680 Auto Suture Bone WaxUnited States Surgical, A Division of Tyco Healthc · 1997
- 5 generations backK041363 Aoc Bone WaxCeremed, Inc. · 2004 · Recalled
- 4 generations backK043133 Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene…Ceremed, Inc. · 2005
- 3 generations backK080507 Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene…Ceremed, Inc. · 2008
- 2 generations backK111323 Synthes Synpor HD Porous Polyethylene Threr Dimensional ImplantsSynthes, Inc. · 2011
- 1 generation backK133809 Osteofab Patient Specific Facial DeviceOxford Performance Materials · 2014
- This deviceK161052 OsteoFab Patient Specific Facial DeviceOxford Performance Materials, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K791495 | Lukens Bone Wax (Gamma Radiation) | Lukens Corp. | 1979 | — |
| −6 | K971680 | Auto Suture Bone Wax | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| −5 | K041363 | Aoc Bone Wax | Ceremed, Inc. | 2004 | 1 |
| −4 | K043133 | Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical… | Ceremed, Inc. | 2005 | — |
| −3 | K080507 | Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical… | Ceremed, Inc. | 2008 | — |
| −2 | K111323 | Synthes Synpor HD Porous Polyethylene Threr Dimensional Implants | Synthes, Inc. | 2011 | — |
| −1 | K133809 | Osteofab Patient Specific Facial Device | Oxford Performance Materials | 2014 | — |
| 0 (this device) | K161052 | OsteoFab Patient Specific Facial Device | Oxford Performance Materials, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 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 KKY? 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 KKY device
- #1 K211514 Longeviti PorousFit implantscore 2.0 · 2 generations · no Class I recall
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K133809 | Osteofab Patient Specific Facial DeviceSummary page 4…/Plastic Surgery Medical Device Classification: Class II Product Code: KKY Predicate Device: Oxford Performance Materials, Inc. OsteoFab® Patient Specific Facial Device (K133809) Description of the Device HTR-PEKK is a custom implant and the shapes and sizes vary within the following specifications: (1)… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 37 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- 6 of the 15 ancestors have a recall of any class.
How does its category compare?
All KKY devicesKKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · KKY
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · KKY
224in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KKY
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KKY
1in 2025
MAUDE reports naming product code KKY, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 4 | 3 |
| 2009 | 0 | — | 0 | 9 |
| 2010 | 1 | — | 0 | 5 |
| 2011 | 1 | — | 0 | 13 |
| 2012 | 0 | — | 0 | 22 |
| 2013 | 1 | — | 1 | 17 |
| 2014 | 3 | 224 | 0 | 9 |
| 2015 | 1 | — | 0 | 18 |
| 2016 | 2 | — | 0 | 25 |
| 2017 | 0 | — | 0 | 19 |
| 2018 | 0 | — | 0 | 17 |
| 2019 | 0 | — | 0 | 20 |
| 2020 | 0 | — | 0 | 13 |
| 2021 | 1 | — | 0 | 12 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The OsteoFab® Patient Specific Facial Device (OPSFD) is designed individually for each patient for enhancement, to correct trauma, and/or to correct defects in facial bone. The OPSFD is also designed individually for non-load bearing enhancement of mandibular bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161052 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161052: OsteoFab Patient Specific Facial Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161052
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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