510(k) · Cleared
ClearedSynthes Synpor HD Porous Polyethylene Threr Dimensional Implants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes, Inc. · KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Cleared on Nov 16, 2011 as substantially equivalent to K080507 (Ceremed, Inc., 2008) after a 189-day review. Its family tree reaches back 5 generations to 1979. 2 later devices descend from it.
- Decided
- Nov 16, 2011
- Review
- 189 days
- Class
- Class II
- Product code
- KKY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K791495 (1979). 9 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK791495 Lukens Bone Wax (Gamma Radiation)Lukens Corp. · 1979
- 4 generations backK971680 Auto Suture Bone WaxUnited States Surgical, A Division of Tyco Healthc · 1997
- 3 generations backK041363 Aoc Bone WaxCeremed, Inc. · 2004 · Recalled
- 2 generations backK043133 Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene…Ceremed, Inc. · 2005
- 1 generation backK080507 Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene…Ceremed, Inc. · 2008
- This deviceK111323 Synthes Synpor HD Porous Polyethylene Threr Dimensional ImplantsSynthes, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK133809 Osteofab Patient Specific Facial DeviceOxford Performance Materials · 2014
- Descendant · 2 generations on · 0 of its ownK161052 OsteoFab Patient Specific Facial DeviceOxford Performance Materials, Inc. · 2016
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 |
|---|---|---|---|---|---|
| −5 | K791495 | Lukens Bone Wax (Gamma Radiation) | Lukens Corp. | 1979 | — |
| −4 | K971680 | Auto Suture Bone Wax | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| −3 | K041363 | Aoc Bone Wax | Ceremed, Inc. | 2004 | 1 |
| −2 | K043133 | Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical… | Ceremed, Inc. | 2005 | — |
| −1 | K080507 | Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical… | Ceremed, Inc. | 2008 | — |
| 0 (this device) | K111323 | Synthes Synpor HD Porous Polyethylene Threr Dimensional Implants | Synthes, Inc. | 2011 | — |
| +1 | K133809 | Osteofab Patient Specific Facial Device | Oxford Performance Materials | 2014 | — |
| +2 | K161052 | OsteoFab Patient Specific Facial Device | Oxford Performance Materials, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K080507 | Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical ImplantSummary page 1…n, for maxillofacial Name reconstruction, Class 11, 21 CFR 878.3500 Product Code KKY Predicate Devices AOC Porous Polyethylene Surgical Implants (K080507) Device SynPOR HD Porous Polyethylene Three Dimensional Implants are Description devices intended for ocular… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133809 | Osteofab Patient Specific Facial Device | 2014 | 1 |
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 32 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K133809 (Oxford Performance Materials, 2014) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K080507.
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. 2011, 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?
Synthes SynPOR HD Porous Polyethylene Three Dimensional Implants are intended for the augmentation or reconstruction of the craniomaxillofacial skeleton.
Specific indications (SynPOR HD Ocular Spheres):
* Ocular reconstruction
* Socket preservation
Specific indications (SynPOR HD Facial Shapes):
* Enhancement of the malar and chin
* Correction of deficiencies of the malar and chin
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111323 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111323: Synthes Synpor HD Porous Polyethylene Threr Dimensional Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111323
Report an extraction error
Are you the manufacturer?
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