510(k) · Cleared
ClearedAPS Metal Plate & Screw System
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 Aug 24, 2023 as substantially equivalent to K041860 (Synthes (Usa), 2004) and 17 other predicates after a 323-day review. Its family tree reaches back 8 generations to 2000.
- Decided
- Aug 24, 2023
- Review
- 323 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 18
Its longest line of descent runs back 8 generations to K000684 (2000). 51 ancestors in all, the oldest K890939 (1989). No later device cites it as a predicate yet.
- Root · 8 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 7 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 6 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 5 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
- 4 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
- 3 generations backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
- 2 generations backK103705 Low Profile ScrewsArthrex, Inc. · 2011
- 1 generation backK131186 Synthes 2.7MM and 3.5MM Variable Angle LCP Midfoot/Hindfoot SystemSynthes (USA) Products, LLC · 2013
- This deviceK223150 APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −7 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −6 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −5 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| −4 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
| −3 | K052614 | Low Profile Plate and Screw System | Arthrex, Inc. | 2005 | — |
| −2 | K103705 | Low Profile Screws | Arthrex, Inc. | 2011 | — |
| −1 | K131186 | Synthes 2.7MM and 3.5MM Variable Angle LCP Midfoot/Hindfoot System | Synthes (USA) Products, LLC | 2013 | — |
| 0 (this device) | K223150 | APS Metal Plate & Screw System | A Plus Biotechnology Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 6 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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? (18)
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 |
|---|---|---|---|
| * | K041860 | Synthes (Usa) LCP Proximal Humerus Plates, LongSummary page 5…roduct Code: HRS (Primary), HWC APS Metal Plate & Screw System Primary Predicate Device SYNTHES (USA) LCP PROXIMAL HUMERUS PLATES, LONG (K041860) Additional Predicate SYNTHES LARGE FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM (K000682… | 2004 |
| * | K000682 | Synthes Large Fragment Dynamic Compression Locking (DCL) SystemSummary page 5…ATES, LONG (K041860) Additional Predicate SYNTHES LARGE FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM (K000682) SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM (K000684)… | 2000 |
| * | K000684 | Small Fragment Dynamic Compression Locking (DCL) SystemSummary page 5…LOCKING (DCL) SYSTEM (K000682) SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM (K000684) SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES (K001945) SYNTHES LOCKING DISTA… | 2000 |
| * | K001945 | Synthes (Usa) Medial Distal Tibia PlatesSummary page 5…SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM (K000684) SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES (K001945) SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM (K012114)… | 2000 |
| * | K012114 | Synthes Locking Distal Radius Plating SystemSummary page 5…SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES (K001945) SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM (K012114) SYNTHES LCP DISTAL TIBIA PLATES (K013248) SYNTHES 3.5MM TITANIUM LCP PRO… | 2001 |
| * | K013248 | Synthes LCP Distal Tibia PlatesSummary page 5…SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM (K012114) SYNTHES LCP DISTAL TIBIA PLATES (K013248) SYNTHES 3.5MM TITANIUM LCP PROXIMAL TIBIA PLATES (K030597)… | 2001 |
| * | K030597 | Synthes 3.5MM Titanium LCP Proximal Tibia PlatesSummary page 5…SYNTHES LCP DISTAL TIBIA PLATES (K013248) SYNTHES 3.5MM TITANIUM LCP PROXIMAL TIBIA PLATES (K030597) SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES (K032269)… | 2003 |
| * | K032269 | Synthes (Usa) 3.5/4.5MM LCP Medial Proximal Tibia PlatesSummary page 5…IMAL TIBIA PLATES (K030597) SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES (K032269) SYNTHES (USA) CLAVICLE HOOK PLATES (K061753) SYNTHES LCP DISTAL FEMUR PL… | 2003 |
| * | K061753 | Synthes (Usa) Clavicle Hook PlatesSummary page 5…SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES (K032269) SYNTHES (USA) CLAVICLE HOOK PLATES (K061753) SYNTHES LCP DISTAL FEMUR PLATES (K062564) SYNTHES (USA) MODULAR MINI FRA… | 2006 |
| * | K062564 | Synthes LCP Distal Femur PlatesSummary page 5…PLATES (K032269) SYNTHES (USA) CLAVICLE HOOK PLATES (K061753) SYNTHES LCP DISTAL FEMUR PLATES (K062564) SYNTHES (USA) MODULAR MINI FRAGMENT LCP SYSTEM Page 1 of… | 2006 |
| * | K063049 | Synthes (Usa) Modular Mini Fragment LCP SystemSummary page 6…CP SYSTEM Page 1 of 6 K223150 (K063049) SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM (K073186) SYNTHES 2.7 MM/3… | 2006 |
| * | K073186 | Synthes 3.5MM LCP Clavicle Plate SystemSummary page 6…K223150 (K063049) SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM (K073186) SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES (K073460)… | 2007 |
| * | K073460 | Synthes 2.7 MM/3.5 MM LCP Distal Fibula PlatesSummary page 6…SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM (K073186) SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES (K073460) SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATES… | 2008 |
| * | K083694 | Synthes (Usa) 2.4 MM VA-LCP Two Column Volar Distal Radius PlatesSummary page 6…(K073460) SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATES (K083694) SYNTHES (USA) 1.5MM MINI FRAGMENT LCP SYSTEM (K090047)… | 2009 |
| * | K090047 | Synthes (Usa) 1.5MM Mini Fragment LCP SystemSummary page 6…DISTAL RADIUS PLATES (K083694) SYNTHES (USA) 1.5MM MINI FRAGMENT LCP SYSTEM (K090047) SYNTHES (USA) 2.4MM LCP VOLAR COLUMN DISTAL RADIUS PLATES (K091644… | 2009 |
| * | K091644 | Synthes (Usa) 2.4MM LCP Volar Column Distal Radius PlatesSummary page 6…SYSTEM (K090047) SYNTHES (USA) 2.4MM LCP VOLAR COLUMN DISTAL RADIUS PLATES (K091644) SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM… | 2009 |
| * | K131186 | Synthes 2.7MM and 3.5MM Variable Angle LCP Midfoot/Hindfoot SystemSummary page 6…PLATES (K091644) SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM (K131186) Acutrak System, Acutrak 2 System (K944330) APS Metal Plate & Device Description Scr… | 2013 |
| * | K944330 | Acutrak Plus Fixation SystemSummary page 6…THES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM (K131186) Acutrak System, Acutrak 2 System (K944330) APS Metal Plate & Device Description Screw System The APS Metal Plate & Screw System… | 1995 |
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 23 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 10 of the 51 ancestors have a recall of any class.
- 35 other devices also cite its predicate K041860.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Locking Screw: The locking screws, in combination with the appropriate locking plate, are indicated for fixation of fractures, osteotomies, non-unions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone of the hand, wrist, foot, and ankle. Cortex Screw: The Cortex Screw is indicated to be used with the APS Metal Plate & Screw System for the fixation of fractures, osteotomies, non-unions, replantations, and…
Read the full statement (643 words)
Locking Screw:
The locking screws, in combination with the appropriate locking plate, are indicated for fixation of fractures, osteotomies, non-unions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone of the hand, wrist, foot, and ankle.
Cortex Screw:
The Cortex Screw is indicated to be used with the APS Metal Plate & Screw System for the fixation of fractures, osteotomies, non-unions, replantations, and fusions involving small bones and bone fragments, especially in osteopenic conditions. Examples include, but are not limited to, the hand, wrist, foot, and ankle.
Star Cancellous Screw:
The Star Cancellous Screw is indicated for the fixation of fractures, osteotomies, and non-unions involving the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, and distal tibia, fibula, particularly in osteopenic bone.
APS HLR Screw:
The APS HLR Screw is indicated for fracture fixation, reconstruction, osteotomy, and arthrodesis of various bones and bone fragments, including joint fusions (arthrodesis) in the foot and fixation of intra-articular fractures of the humerus, femur, and tibia.
Distal CAS Locking Plate:
The Distal CAS Locking Plate is indicated for fixation of fractures, malunions, non-unions, and osteotomies of the distal (lateral) clavicle.
Distal Clavicle Hook Locking Plate | Clavicle Anatomical Midshaft Locking Plate:
The Distal Clavicle Hook Locking Plate and Clavicle Anatomical Midshaft Locking Plate are indicated for the fixation of distal (lateral) clavicle fractures, mid-shaft clavicle fractures, and dislocations of the acromioclavicular joint.
Distal Medial Humeral Locking Plate | Proximal Humeral Locking Plate:
The Distal Medial Humeral Locking Plate and Proximal Humeral Locking Plate are indicated for fractures and fracture dislocations, osteotomies, and non-unions of the distal (medial) and proximal humerus, particularly in osteopenic bone.
Small ABS Locking Plate | Dynamic Compression Locking Plate:
The Small ABS Locking Plate and Dynamic Compression Locking Plate are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.
Distal Radial Locking Plate | Trident Distal Radial Locking Plate:
The Distal Radial Locking Plate and Trident Distal Radial Locking Plate are indicated for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.
Distal Lateral Femoral Locking Plate:
The Distal Lateral Femoral Locking Plate is indicated for buttressing multi-fragmentary distal femur fractures, including supracondylar, intra-articular and extra-articular condylar, peri-prosthetic fractures, and fractures in normal or osteopenic bone, non-unions and mal-unions, and osteotomies of the femur.
Large ABS Locking Plate:
The Large ABS Locking Plate is indicated for fixation of various long bones, such as the humerus, femur, and tibia. It is also for use in the fixation of osteopenic bone and fixation of non-unions or mal-unions.
Distal FDH Locking Plate:
The Distal FDH Locking Plate is indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, especially in osteopenic bone.
Distal Tibia Locking Plate System (Antero Lateral Distal Tibial Locking Plate, Distal Medial Tibial Locking Plate):
The Distal Tibia Locking Plate System is indicated for fractures, osteotomies, and non-unions of the distal tibia, especially in osteopenic bone.
Proximal Medial Tibial Locking Plate:
The Proximal Medial Tibial Locking Plate is indicated for buttressing metaphyseal fractures of the medial tibial plateau, split-type fractures of the medial tibial plateau, and medial split fractures with associated depression fractures of the medial tibial plateau.
Calcaneal Locking Plate:
The Calcaneal Locking Plate is indicated for addressing complex fractures and osteotomies of the calcaneus, including, but not limited to, extra-articular, intra-articular, joint depression, tongue-type, and severely comminuted fractures.
Distal RAF Locking Plate:
The Distal RAF Locking Plate is indicated for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.
Mini Locking Plate System:
The Mini Locking Plate System is indicated for fixation of fractures, osteotomies, non-unions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223150 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223150: APS Metal Plate & Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223150
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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