510(k) · Cleared
ClearedOsteo Anatomical Bone Plates
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteonics Corp. · HRS Plate, Fixation, Bone
Cleared on Aug 25, 1997 after a 76-day review. The FDA summary names its predicate without a number. 18 later devices descend from it.
- Decided
- Aug 25, 1997
- Review
- 76 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 1 citing it directly.
- This deviceK972196 Osteo Anatomical Bone PlatesOsteonics Corp. · 1997
- Descendant · cites it directly · 17 of its ownK982545 BMP Cable SystemBiomet, Inc. · 1998 · Recalled
- Descendant · 2 generations on · 10 of its ownK031162 Smith & Nephew Orthopaedic Cabling SystemSmith & Nephew, Inc. · 2003
- Descendant · 3 generations on · 3 of its ownK203405 EVOS Large Fragment Plating SystemSmith & Nephew, Inc. · 2021
- Descendant · 4 generations on · 2 of its ownK213126 Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc…Smith & Nephew, Inc. · 2022 · Recalled
- Descendant · 3 generations on · 1 of its ownK223762 Smith & Nephew ACCORD™ Cable SystemSmith & Nephew · 2023
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K982545BMP Cable SystemBiomet, Inc. · 1998 · cites it directly17descendants
- K031162Smith & Nephew Orthopaedic Cabling SystemSmith & Nephew, Inc. · 2003 · 2 generations on10descendants
- K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc. · 2021 · 3 generations on3descendants
- K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc. · 2022 · 4 generations on2descendants
- K223762Smith & Nephew ACCORD™ Cable SystemSmith & Nephew · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972196 | Osteo Anatomical Bone Plates | Osteonics Corp. | 1997 | — |
| +1 | K982545 | BMP Cable System | Biomet, Inc. | 1998 | 1 |
| +2 | K031162 | Smith & Nephew Orthopaedic Cabling System | Smith & Nephew, Inc. | 2003 | — |
| +3 | K203405 | EVOS Large Fragment Plating System | Smith & Nephew, Inc. | 2021 | — |
| +4 | K213126 | Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100… | Smith & Nephew, Inc. | 2022 | 1 |
| +3 | K223762 | Smith & Nephew ACCORD™ Cable System | Smith & Nephew | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | — | Bone plates offered by Waldemar Link GmbH & Co. Named without a submission number | |
| * | — | Bone plates offered by Synthes Named without a submission number | |
| * | — | Bone plates offered by Osteo AG Named without a submission number |
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982545 | BMP Cable System | 1998 | 17 |
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, K982545 (Biomet, Inc., 1998) has gone furthest, with 17 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 indications for the use of these bone plates, in keeping with those of other legally marketed bone plates, are as follows.
The Osteo Anatomical Bone Plates are intended for internal fracture fixation of various long bones.
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/K972196 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972196: Osteo Anatomical Bone Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972196
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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