510(k) · Cleared
ClearedOsteosymbionics, ST Temporalis Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteosymbionics, LLC · MNF Implant, Temporal
Cleared on Sep 22, 2011 as substantially equivalent to K943644 (Implantech Associates, Inc., 1994) and 1 other predicate after a 157-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Sep 22, 2011
- Review
- 157 days
- Class
- Class II
- Product code
- MNF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K943644 (1994). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK943644 Implantech Temporal ImplantImplantech Associates, Inc. · 1994
- This deviceK111069 Osteosymbionics, ST Temporalis ImplantOsteosymbionics, LLC · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K943644 | Implantech Temporal Implant | Implantech Associates, Inc. | 1994 | — |
| 0 (this device) | K111069 | Osteosymbionics, ST Temporalis Implant | Osteosymbionics, LLC | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 MNF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K943644 | Implantech Temporal ImplantSummary page 1…ade from silicone elastomer technology) are substantially equivalent to the following legally marketed predicate devices: Implantech, Inc., Implantech Temporal Implant - K943644 (made from silicone elastomer) and Porex Surgical, Inc., Medpor Pterional Surgical Implant - K002568, made from porous polyethyle… | 1994 |
| * | K002586 | Medpor Pterional Surgical Implant Our reading of the summary gave K002568, FDA’s number for Polymer Coat, Powder Free, Latex Examination Gloves with… (Smart Glove Corp. Sdn Bhd). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Medpor Pterional Surgical Implant”. | 2000 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All MNF devicesMNF Implant, Temporal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MNF
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · MNF
Too few MNF 510(k)s in any year since 2007 to give a median.
Recalls per year · MNF
No recall names MNF since 2007.
Adverse event reports per year · MNF
1in 2013
MAUDE reports naming product code MNF, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The OsteoSymbionics ST Temporalis Implant is indicated to correct temporal hollowing in patients who have had surgery involving the pterional / lateral approach to the cranium, including pterional / lateral craniotomy or decompressive craniectomy. The OsteoSymbionics ST Temporalis Implant augments the space normally occupied by the temporalis muscle. The implant is used for the reconstruction of temporal contour deformities; the reconstruction of temporal defects, and / or the augmentation / reconstruction of the space normally occupied by the temporalis muscle / temporal area (s).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111069 · printed Nov 3, 2026
Cite this page
510(k) Report. “K111069: Osteosymbionics, ST Temporalis Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K111069
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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