510(k) · Cleared
ClearedAirlock osteosynthesis plate system
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novastep · HRS Plate, Fixation, Bone
Cleared on Apr 6, 2015 as substantially equivalent to K083447 (Memometal Technologies, 2009) after a 115-day review. Its family tree reaches back 3 generations to 2002. 4 later devices descend from it.
- Decided
- Apr 6, 2015
- Review
- 115 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K022325 (2002). 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK022325 Normed Titanium Osteotomy Plating SystemOsteomedics, Inc. · 2002 · Recalled
- 2 generations backK061808 Darco Locking Bone Plate SystemDarco International, Inc. · 2006 · Recalled
- 1 generation backK083447 Memometal Anchorage Bone Plate System, Models PLSS/PLSL…Memometal Technologies · 2009
- This deviceK143523 Airlock osteosynthesis plate systemNovastep · 2015
- Descendant · cites it directly · 2 of its ownK192356 Airlock Centrolock Osteosynthesis Implant SystemNovastep · 2019
- Descendant · 2 generations on · 1 of its ownK253718 enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK262098 EnHAnce PEEK Bunion SystemNvision Biomedical Technologies · 2026
- Descendant · cites it directly · 0 of its ownK260274 Airlock® Ankle Plating SystemNovastep SAS · 2026
Most influential descendants
Showing 4 of 4 · See all- K192356Airlock Centrolock Osteosynthesis Implant SystemNovastep · 2019 · cites it directly2descendants
- K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc. · 2026 · 2 generations on1descendant
- K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies · 2026 · 3 generations on0descendants
- K260274Airlock® Ankle Plating SystemNovastep SAS · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K022325 | Normed Titanium Osteotomy Plating System | Osteomedics, Inc. | 2002 | 1 |
| −2 | K061808 | Darco Locking Bone Plate System | Darco International, Inc. | 2006 | 3 |
| −1 | K083447 | Memometal Anchorage Bone Plate System, Models PLSS/PLSL… | Memometal Technologies | 2009 | — |
| 0 (this device) | K143523 | Airlock osteosynthesis plate system | Novastep | 2015 | — |
| +1 | K192356 | Airlock Centrolock Osteosynthesis Implant System | Novastep | 2019 | — |
| +2 | K253718 | enHAnce PEEK Bunion System | Nvision Biomedical Technologies, Inc. | 2026 | — |
| +3 | K262098 | EnHAnce PEEK Bunion System | Nvision Biomedical Technologies | 2026 | — |
| +1 | K260274 | Airlock® Ankle Plating System | Novastep SAS | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2026 | 3 | 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? (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 |
|---|---|---|---|
| * | K083447 | Memometal Anchorage Bone Plate System, Models PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50Summary page 4…e Single / Multiple component metallic bone fixation appliances and accessories (21CFR 888.3030, product code HRS) Regulatory class Il Legally marketed 510(k) number: K083447 redicate devices predicate devi Device name: Anchorage® Bone Plate System Original applicant: MEMOMETAL TECHNOLOGIES. Descripti… | 2009 |
What descends from it? (4)
2 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?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K192356 (Novastep, 2019) has gone furthest, with 2 descendants of its own.
- 9 other devices also cite its predicate K083447.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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?
Airlock® osteosynthesis plate systems are indicated for fixation and stabilization of fresh fractures, revision procedures,
joint fusion and reconstruction of small bones of the hand., feet, wrist, ankles, fingers and toes. The system may be used in
both adult and pediatric patients.
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/K143523 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143523: Airlock osteosynthesis plate system.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143523
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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