510(k) · Cleared
ClearedAPS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw); APS Osteotomy Fixation System (0850-4302-xx / 5.0mm Locking Screw); APS Osteotomy Fixation System (0701-xx10(1)-05 / Proximal Medial Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0701-xx60(1)-0x / Proximal Medial Tibial Osteotomy Locking Plate, Small); APS Osteotomy Fixation System (0702-xx00(1)-03 / Proximal Lateral Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0501-xx00(1)-04 / Dista
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
A Plus Biotechnology Co., Ltd. · HRS Plate, Fixation, Bone
Cleared on Dec 11, 2025 as substantially equivalent to K023941 (Synthes (Usa), 2003) after a 91-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Dec 11, 2025
- Review
- 91 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K023941 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK023941 Synthes Tomofix Osteotomy SystemSynthes (Usa) · 2003 · Recalled
- This deviceK252897 APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw)…A Plus Biotechnology Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K023941 | Synthes Tomofix Osteotomy System | Synthes (Usa) | 2003 | 1 |
| 0 (this device) | K252897 | APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw); APS… | A Plus Biotechnology Co., Ltd. | 2025 | — |
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 |
|---|---|---|---|
| * | K023941 | Synthes Tomofix Osteotomy SystemSummary page 6…21 CFR 807.92(a)(3) Predicate# Predicate Trade Name (Primary Predicate is listed first) Product Code I K023941 11 SYNTHES TOMOFIX OSTEOTOMY SYSTEM Device Description Summary… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has a recall.
- 8 other devices also cite its predicate K023941.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
The 4.5 mm Cortical Screw is intended for use only in conjunction with compatible plates of the APS Osteotomy Fixation System. It is indicated for fixation of long bone fractures and bone fissures where high-strength cortical fixation is required as part of the plate-and-screw construct. The screw provides stable support at the fixation site when used as a component of the APS Osteotomy Fixation System. This screw is not intended for standalone use. The…
Read the full statement (322 words)
The 4.5 mm Cortical Screw is intended for use only in conjunction with compatible plates of the APS Osteotomy Fixation System. It is indicated for fixation of long bone fractures and bone fissures where high-strength cortical fixation is required as part of the plate-and-screw construct. The screw provides stable support at the fixation site when used as a component of the APS Osteotomy Fixation System. This screw is not intended for standalone use.
The 5.0 mm Locking Screw is intended for use only with compatible locking plates of the APS Osteotomy Fixation System. It is indicated for fixation of long bone fractures requiring angular stability and reliable screw-plate interface fixation as part of the system construct. The locking mechanism is designed to reduce screw loosening and enhance stability at the fixation site. This screw is not intended for standalone use.
The Proximal Medial Tibial Osteotomy Locking Plate is indicated to be used in deformity correction and osteotomy procedures, providing fixation in general surgeries, reconstructive surgeries, and bone fusion or osteotomy procedures on the proximal medial tibia.
The “Proximal Medial Tibial Osteotomy Locking Plate, Small” is designed for high tibial osteotomy. It is indicated for use in deformity correction and osteotomy, providing fixation in general and reconstructive surgeries, as well as bone fusion or osteotomy procedures.
The Proximal Lateral Tibial Osteotomy Locking Plate is indicated to be used in deformity correction and osteotomy of the proximal lateral tibia, offering fixation in general surgeries, reconstructive surgeries, and bone fusion or osteotomy procedures.
The Distal Medial Femoral Osteotomy Locking Plate is indicated to be used in deformity correction and osteotomy of the distal medial femur. It provides fixation in general surgeries, reconstructive surgeries, and bone fusion or osteotomy procedures.
The Distal Lateral Femoral Osteotomy Locking Plate is indicated to be used in deformity correction and osteotomy of the distal lateral femur. It provides fixation in general surgeries, reconstructive surgeries, and bone fusion or osteotomy procedures.
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/K252897 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252897: APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw); APS Osteotomy Fixation System (0850-4302-xx / 5.0mm Locking Screw); APS Osteotomy Fixation System (0701-xx10(1)-05 / Proximal Medial Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0701-xx60(1)-0x / Proximal Medial Tibial Osteotomy Locking Plate, Small); APS Osteotomy Fixation System (0702-xx00(1)-03 / Proximal Lateral Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0501-xx00(1)-04 / Dista.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252897
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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