510(k) · Cleared
ClearedOtis -C Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sciences ET Bio Materiaux (Sbm) · HRS Plate, Fixation, Bone
Cleared on Jun 14, 2010 as substantially equivalent to K041709 (Howmedica Osteonics Corp., 2004) and 1 other predicate after a 103-day review. Its family tree reaches back 1 generation to 1998. 2 later devices descend from it.
- Decided
- Jun 14, 2010
- Review
- 103 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K973812 (1998). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK973812 Arthrex Puddu Osteotomy SystemArthrex, Inc. · 1998
- This deviceK100604 Otis -C PlusSciences ET Bio Materiaux (Sbm) · 2010
- Descendant · cites it directly · 1 of its ownK120818 Otis-C PlusScience For Biomaterials · 2012
- Descendant · cites it directly · 0 of its ownK140226 Otis-C-Plus, Neotis Plate, Screw 06.5Science For Biomaterials · 2014
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 |
|---|---|---|---|---|---|
| −1 | K973812 | Arthrex Puddu Osteotomy System | Arthrex, Inc. | 1998 | — |
| 0 (this device) | K100604 | Otis -C Plus | Sciences ET Bio Materiaux (Sbm) | 2010 | — |
| +1 | K120818 | Otis-C Plus | Science For Biomaterials | 2012 | — |
| +1 | K140226 | Otis-C-Plus, Neotis Plate, Screw 06.5 | Science For Biomaterials | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 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? (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 |
|---|---|---|---|
| * | K041709 | Numelock II SystemSummary page 1…HOPEDIC Product Code HRS: PLATE, FIXATION, BONE HWC :SCREW, FIXATION, BONE Class II Legally marketed K041709 NUMELOCK II SYSTEM manufactured by predicate devices H-OWMEDICA OSTEONICS CORP… | 2004 |
| * | K973812 | Arthrex Puddu Osteotomy SystemSummary page 1…ufactured by predicate devices H-OWMEDICA OSTEONICS CORP (now STRYKER ORTHOPAEDICS) and K973812 ARTHREX PUDDU OSTEOTOMY SYSTEM manufactured by ARTHREX, INC. Submitter SCIENCE FO… | 1998 |
What descends from it? (2)
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?
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
OTIS-C Plus is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial Opening wedge osteotomnies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100604 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100604: Otis -C Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100604
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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