510(k) · Cleared
ClearedMedpar Surgical Implants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Porex Medical · FWP Prosthesis, Chin, Internal
Cleared on May 10, 1984 after a 303-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 36 later devices descend from it.
- Decided
- May 10, 1984
- Review
- 303 days
- Class
- Class II
- Product code
- FWP
- Recalls
- None
- Predicates
- 0
36 later devices descend from it, 2 citing it directly.
- This deviceK832283 Medpar Surgical ImplantsPorex Medical · 1984
- Descendant · cites it directly · 34 of its ownK053199 Synthes Patient Specific Cranial/Craniofacial ImplantSynthes (Usa) · 2005
- Descendant · 2 generations on · 17 of its ownK062570 Patient Contoured Mesh (PCM)KLS-Martin L.P. · 2006
- Descendant · 2 generations on · 13 of its ownK121153 Peek Customized Craial Implant KitStryker · 2012
- Descendant · 2 generations on · 13 of its ownK072707 Patient Contoured Mesh-Peek (PCM-P)KLS-Martin L.P. · 2007
- Descendant · 2 generations on · 8 of its ownK103582 Kelyniam Custom Skull Implant (Csi)Kelyniam Global, Inc. · 2011 · Recalled
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K053199Synthes Patient Specific Cranial/Craniofacial ImplantSynthes (Usa) · 2005 · cites it directly34descendants
- K062570Patient Contoured Mesh (PCM)KLS-Martin L.P. · 2006 · 2 generations on17descendants
- K121153Peek Customized Craial Implant KitStryker · 2012 · 2 generations on13descendants
- K072707Patient Contoured Mesh-Peek (PCM-P)KLS-Martin L.P. · 2007 · 2 generations on13descendants
- K103582Kelyniam Custom Skull Implant (Csi)Kelyniam Global, Inc. · 2011 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K832283 | Medpar Surgical Implants | Porex Medical | 1984 | — |
| +1 | K053199 | Synthes Patient Specific Cranial/Craniofacial Implant | Synthes (Usa) | 2005 | — |
| +2 | K062570 | Patient Contoured Mesh (PCM) | KLS-Martin L.P. | 2006 | — |
| +2 | K121153 | Peek Customized Craial Implant Kit | Stryker | 2012 | — |
| +2 | K072707 | Patient Contoured Mesh-Peek (PCM-P) | KLS-Martin L.P. | 2007 | — |
| +2 | K103582 | Kelyniam Custom Skull Implant (Csi) | Kelyniam Global, Inc. | 2011 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 5 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FWP? 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 FWP device
- #1 K254233 MEDPOR Customized Implant Kitscore 13.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (36)
See all 362 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K053199 (Synthes (Usa), 2005) has gone furthest, with 34 descendants of its own.
How does its category compare?
All FWP devicesFWP Prosthesis, Chin, Internal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FWP
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · FWP
Too few FWP 510(k)s in any year since 2007 to give a median.
Recalls per year · FWP
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FWP
17in 2025
MAUDE reports naming product code FWP, 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 | 0 | — | 0 | 3 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 1 | — | 0 | 5 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 22 |
| 2012 | 1 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 1 | — | 0 | 5 |
| 2015 | 1 | — | 0 | 8 |
| 2016 | 2 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 13 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 2 | — | 0 | 15 |
| 2020 | 1 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 13 |
| 2022 | 0 | — | 0 | 12 |
| 2023 | 1 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 10 |
| 2025 | 0 | — | 1 | 17 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K832283 · printed Nov 6, 2026
Cite this page
510(k) Report. “K832283: Medpar Surgical Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K832283
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026