510(k) · Cleared
ClearedEpitec Titanium Implant System for the Surgical Anchoring of Facial Prostheses
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Leibinger, Inc. · HRS Plate, Fixation, Bone
Cleared on Jul 17, 1997 after a 441-day review. The FDA summary names no predicate by number. 3 later devices descend from it.
- Decided
- Jul 17, 1997
- Review
- 441 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK961719 Epitec Titanium Implant System for the Surgical Anchoring of Facial…Howmedica Leibinger, Inc. · 1997
- Descendant · cites it directly · 2 of its ownK990458 Straumann Extraoral Implant SystemStraumann USA · 1999
- Descendant · 2 generations on · 1 of its ownK161548 Osseointegrated FixturesSouthern Implants (Pty), Ltd. · 2016
- Descendant · 3 generations on · 0 of its ownK241253 Medicon Epiplating SystemCmf Medicon Surgical, Inc. · 2024
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961719 | Epitec Titanium Implant System for the Surgical Anchoring of Facial Prostheses | Howmedica Leibinger, Inc. | 1997 | — |
| +1 | K990458 | Straumann Extraoral Implant System | Straumann USA | 1999 | — |
| +2 | K161548 | Osseointegrated Fixtures | Southern Implants (Pty), Ltd. | 2016 | — |
| +3 | K241253 | Medicon Epiplating System | Cmf Medicon Surgical, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2016 | 1 | 0 |
| 2024 | 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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990458 | Straumann Extraoral Implant System | 1999 | 2 |
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, K990458 (Straumann USA, 1999) has gone furthest, with 2 descendants of its own.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The Epitec system can be used for the fixation of diverse kinds of craniofacial prostheses, including the following examples:
Ear prostheses
Orbital prostheses
Nose prostheses
Cheek prostheses
Hair Pieces
Although the Epitec system will primarily be used for the alloplastic reconstruction of craniofacial defects caused by genetic anomalies, tumor resections, or trauma, it can also be used in other craniofacial cases best treated with surgical anchoring.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961719 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961719: Epitec Titanium Implant System for the Surgical Anchoring of Facial Prostheses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961719
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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