510(k) · Cleared
ClearedMetagen High Tibial Osteotomy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Metagen, LLC · HRS Plate, Fixation, Bone
Cleared on Feb 12, 1997 after a 149-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.
- Decided
- Feb 12, 1997
- Review
- 149 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK963700 Metagen High Tibial Osteotomy SystemMetagen, LLC · 1997
- Descendant · cites it directly · 7 of its ownK022139 Hip Tool ImplantOrthopedic Sciences, Inc. · 2002
- Descendant · 2 generations on · 1 of its ownK063709 TS-Bone Hip ToolOrthopedic Sciences, Inc. · 2007
- Descendant · 2 generations on · 1 of its ownK040850 Tsy Shoulder Plate ImplantOrthopedic Sciences, Inc. · 2004
- Descendant · 3 generations on · 0 of its ownK072175 Titanium Hip Tool Locking PlateOrthopedic Sciences, Inc. · 2007
- Descendant · 3 generations on · 0 of its ownK063033 Modification to Titanium Shoulder Plate ImplantOrthopedic Sciences, Inc. · 2006
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K022139Hip Tool ImplantOrthopedic Sciences, Inc. · 2002 · cites it directly7descendants
- K063709TS-Bone Hip ToolOrthopedic Sciences, Inc. · 2007 · 2 generations on1descendant
- K040850Tsy Shoulder Plate ImplantOrthopedic Sciences, Inc. · 2004 · 2 generations on1descendant
- K072175Titanium Hip Tool Locking PlateOrthopedic Sciences, Inc. · 2007 · 3 generations on0descendants
- K063033Modification to Titanium Shoulder Plate ImplantOrthopedic Sciences, Inc. · 2006 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963700 | Metagen High Tibial Osteotomy System | Metagen, LLC | 1997 | — |
| +1 | K022139 | Hip Tool Implant | Orthopedic Sciences, Inc. | 2002 | — |
| +2 | K063709 | TS-Bone Hip Tool | Orthopedic Sciences, Inc. | 2007 | — |
| +2 | K040850 | Tsy Shoulder Plate Implant | Orthopedic Sciences, Inc. | 2004 | — |
| +3 | K072175 | Titanium Hip Tool Locking Plate | Orthopedic Sciences, Inc. | 2007 | — |
| +3 | K063033 | Modification to Titanium Shoulder Plate Implant | Orthopedic Sciences, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 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? (8)
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 |
|---|---|---|---|
| * | — | NexGen Osteotomy System (Zimmer) Named without a submission number | |
| * | — | Natural Knee Family High Tibial Osteotomy System (Intermedics Orthopedics) Named without a submission number | |
| * | — | High Tibial Osteotomy System (Richards) Named without a submission number | |
| * | — | L-buttress, T-buttress and T-plates (Synthes) Named without a submission number | |
| * | — | ECT Internal Fracture Fixation System (Zimmer) Named without a submission number | |
| * | — | Improved Geibel Blade Plates (Link America Inc.) Named without a submission number | |
| * | — | Osteo Auto-Compression Plating System (Smith & Nephew Richards) Named without a submission number | |
| * | — | May Anatomical Bone Plates (Waldemar Link) Named without a submission number |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022139 | Hip Tool Implant | 2002 | 7 |
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, K022139 (Orthopedic Sciences, Inc., 2002) has gone furthest, with 7 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 Metagen High Tibial Osteotomy System consists of single use devices, intended to be used for the fixation of fractures of the proximal or distal end of long bones, or to stabilize the fracture site during the healing process following surgical procedures that involve cutting the bone, such as tibial osteotomies.
Tibial osteotomy is indicated in young, active patients with painful unicompartmental osteoarthritis associated with varus deformity of no more than 11 degrees, and for deformity incident to rheumatoid arthritis and trauma in selected cases.
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/K963700 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963700: Metagen High Tibial Osteotomy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963700
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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