510(k) · Cleared
ClearedAPS Spear Locking Plate
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 Mar 17, 2026 as substantially equivalent to K101962 (Orthohelix Surgical Designs, Inc., 2010) and 1 other predicate after a 90-day review. Its family tree reaches back 8 generations to 1996.
- Decided
- Mar 17, 2026
- Review
- 90 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K954385 (1996). 29 ancestors in all, the oldest K920738 (1992). No later device cites it as a predicate yet.
- Root · 8 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 7 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 6 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 5 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 4 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 3 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 2 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 1 generation backK101962 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2010 · Recalled
- This deviceK254053 APS Spear Locking PlateA Plus Biotechnology Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −7 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −6 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −5 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −4 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −3 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −2 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −1 | K101962 | Mini Maxlock Extreme Plating System | Orthohelix Surgical Designs, Inc. | 2010 | 1 |
| 0 (this device) | K254053 | APS Spear Locking Plate | A Plus Biotechnology Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 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? (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 |
|---|---|---|---|
| * | K101962 | Mini Maxlock Extreme Plating SystemSummary page 5…3030 Product Code(s) HRS, HWC I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K101962 Mini MaxLock Extreme Plating System HRS K033975 SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS HWC Device Description Summary 21 CF… | 2010 |
| * | K033975 | Synthes 2.4 MM Titanium (TI.) Locking ScrewsSummary page 5…d Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K101962 Mini MaxLock Extreme Plating System HRS K033975 SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS HWC Device Description Summary 21 CFR 807.92(a)(4) The APS Spear Locking Plate Syst… | 2004 |
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?
- The line of descent spans 30 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 7 of the 29 ancestors have a recall of any class.
- 6 other devices also cite its predicate K101962.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 APS Spear Locking Plate System is indicated for use in small bone reconstruction, corrective osteotomies, and fracture fixation. 2.4mm Locking Screw The 2.4mm Locking Screw is intended for use with the Spear Locking Plate in metacarpal and metatarsal reconstruction, corrective osteotomies, and fracture fixation. 2.7mm Continuous Locking Screw The 2.7mm Continuous Locking Screw is intended for use with the Spear Locking Plate, for fixation and…
Read the full statement (127 words)
The APS Spear Locking Plate System is indicated for use in small bone reconstruction, corrective osteotomies, and fracture fixation.
2.4mm Locking Screw
The 2.4mm Locking Screw is intended for use with the Spear Locking Plate in metacarpal and metatarsal reconstruction, corrective osteotomies, and fracture fixation.
2.7mm Continuous Locking Screw
The 2.7mm Continuous Locking Screw is intended for use with the Spear Locking Plate, for fixation and compression at the osteotomy or fracture site. It is suitable for metacarpal and metatarsal corrective osteotomies and fracture stabilization.
Spear Locking Plate
The Spear Locking Plate is intended for use in metacarpal and metatarsal reconstruction, corrective osteotomies, and fracture fixation.
Spear Locking Plate II
The Spear Locking Plate II is intended for metacarpal and metatarsal reconstruction, corrective osteotomies, and fracture fixation.
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/K254053 · printed Nov 4, 2026
Cite this page
510(k) Report. “K254053: APS Spear Locking Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K254053
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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