510(k) · Cleared
ClearedA.L.P.S. Small Fragment Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Orthopedics · HRS Plate, Fixation, Bone
Cleared on Feb 19, 2025 as substantially equivalent to K111663 (DePuy Orthopaedics, Inc., 2012) and 4 other predicates after a 75-day review. Its family tree reaches back 8 generations to 1996.
- Decided
- Feb 19, 2025
- Review
- 75 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K962616 (1996). 97 ancestors in all, the oldest K791619 (1979). No later device cites it as a predicate yet.
- Root · 8 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 7 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 6 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 5 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 4 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 3 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 2 generations backK060864 Multidirectional Threaded PegHand Innovations, LLC · 2006
- 1 generation backK111663 Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc. · 2012 · Recalled
- This deviceK243761 A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −7 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −6 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −5 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −4 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −3 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −2 | K060864 | Multidirectional Threaded Peg | Hand Innovations, LLC | 2006 | — |
| −1 | K111663 | Trauma Internal Fixation Systems | DePuy Orthopaedics, Inc. | 2012 | 17 |
| 0 (this device) | K243761 | A.L.P.S. Small Fragment Plating System | Biomet Orthopedics | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 3 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 6 | 0 |
| 1998 | 7 | 0 |
| 1999 | 4 | 0 |
| 2000 | 6 | 0 |
| 2001 | 7 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 7 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 6 | 0 |
| 2010 | 4 | 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? (5)
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 |
|---|---|---|---|
| * | K111663 | Trauma Internal Fixation SystemsSummary page 5…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K111663 TRAUMA INTERNAL FIXATION SYSTEMS HRS K072083 SMALL FRAG… | 2012 |
| * | K072083 | Small Fragment Locking Plating SystemSummary page 5…ame (Primary Predicate is listed first) Product Code K111663 TRAUMA INTERNAL FIXATION SYSTEMS HRS K072083 SMALL FRAGMENT LOCKING PLATING SYSTEM HRS K920738 ACE 100 DE… | 2007 |
| * | K920738 | Ace 100 Degrees Tubular PlateSummary page 5…INTERNAL FIXATION SYSTEMS HRS K072083 SMALL FRAGMENT LOCKING PLATING SYSTEM HRS K920738 ACE 100 DEGREES TUBULAR PLATE HRS K895107 ACE ORTHOP… | 1992 |
| * | K895107 | Ace Orthopaedic WashersSummary page 5…FRAGMENT LOCKING PLATING SYSTEM HRS K920738 ACE 100 DEGREES TUBULAR PLATE HRS K895107 ACE ORTHOPAEDIC WASHERS HTN K083843 LOCKING AN… | 1989 |
| * | K083843 | Locking Anatomic & Composite Plating SystemSummary page 5…0 DEGREES TUBULAR PLATE HRS K895107 ACE ORTHOPAEDIC WASHERS HTN K083843 LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM HRS Device Description Summary… | 2009 |
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 29 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 24 of the 97 ancestors have a recall of any class.
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 A.L.P.S. Small Fragment Plating System is intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.
The 100 Degree Tubular Plate is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius, ulna, distal tibia (including intra-articular), fibula, particularly in osteopenic bone.
Washers are intended to be used in conjunction with bone screws.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243761 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243761: A.L.P.S. Small Fragment Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243761
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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