510(k) · Cleared
ClearedArthrex Plates, Screws, and Staples
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · HRS Plate, Fixation, Bone
Cleared on Apr 29, 2015 as substantially equivalent to K014155 (Arthrex, Inc., 2002) and 6 other predicates after a 68-day review. Its family tree reaches back 9 generations to 2000. 6 later devices descend from it.
- Decided
- Apr 29, 2015
- Review
- 68 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 9 generations to K000684 (2000). 59 ancestors in all, the oldest K885250 (1989). 6 later devices descend from it, 4 citing it directly.
- Root · 9 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 5 generations between
- 3 generations backK103705 Low Profile ScrewsArthrex, Inc. · 2011
- 2 generations backK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
- 1 generation backK131474 Arthrex Distal Radius Plate SystemArthrex, Inc. · 2013
- This deviceK150456 Arthrex Plates, Screws, and StaplesArthrex, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK250920 Arthrex Spine Compression FT ScrewArthrex, Inc. · 2025
- Descendant · cites it directly · 1 of its ownK222267 Arthrex 2.4 mm Volar Distal Radius Plate SystemArthrex, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK262618 Arthrex Spine Compression FT ScrewArthrex, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK252807 Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesArthrex, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK243368 Montblanc Plate SystemMedifield Medical Co., Ltd. · 2025
Show all 9 generations
- Root · 9 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 8 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 7 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 6 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
- 5 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
- 4 generations backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
- 3 generations backK103705 Low Profile ScrewsArthrex, Inc. · 2011
- 2 generations backK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
- 1 generation backK131474 Arthrex Distal Radius Plate SystemArthrex, Inc. · 2013
- This deviceK150456 Arthrex Plates, Screws, and StaplesArthrex, Inc. · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K250920Arthrex Spine Compression FT ScrewArthrex, Inc. · 2025 · cites it directly1descendant
- K222267Arthrex 2.4 mm Volar Distal Radius Plate SystemArthrex, Inc. · 2022 · cites it directly1descendant
- K262618Arthrex Spine Compression FT ScrewArthrex, Inc. · 2026 · 2 generations on0descendants
- K252807Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesArthrex, Inc. · 2026 · cites it directly0descendants
- K243368Montblanc Plate SystemMedifield Medical Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −8 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −7 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −6 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| −5 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
| −4 | K052614 | Low Profile Plate and Screw System | Arthrex, Inc. | 2005 | — |
| −3 | K103705 | Low Profile Screws | Arthrex, Inc. | 2011 | — |
| −2 | K111253 | Arthrex Distal Extremity Plate System | Arthrex, Inc. | 2011 | — |
| −1 | K131474 | Arthrex Distal Radius Plate System | Arthrex, Inc. | 2013 | — |
| 0 (this device) | K150456 | Arthrex Plates, Screws, and Staples | Arthrex, Inc. | 2015 | — |
| +1 | K250920 | Arthrex Spine Compression FT Screw | Arthrex, Inc. | 2025 | — |
| +1 | K222267 | Arthrex 2.4 mm Volar Distal Radius Plate System | Arthrex, Inc. | 2022 | — |
| +2 | K262618 | Arthrex Spine Compression FT Screw | Arthrex, Inc. | 2026 | — |
| +1 | K252807 | Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates | Arthrex, Inc. | 2026 | — |
| +2 | K243368 | Montblanc Plate System | Medifield Medical Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 9 | 0 |
| 1998 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 5 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2013 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (7)
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 |
|---|---|---|---|
| * | K014155 | Opening/Closing Wedge Ostetomy PlatesSummary page 4…21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener Predicate Device K014155: Arthrex Modified Osteotomy System K041965: Arthrex Humeral Fracture Plates & Screws… | 2002 |
| * | K041965 | Arthrex Humeral Fracture Plates and ScrewsSummary page 4…bone fixation fastener Predicate Device K014155: Arthrex Modified Osteotomy System K041965: Arthrex Humeral Fracture Plates & Screws K080111: Arthrex Compression Staple… | 2004 |
| * | K080111 | Arthrex Compression StapleSummary page 4…e Device K014155: Arthrex Modified Osteotomy System K041965: Arthrex Humeral Fracture Plates & Screws K080111: Arthrex Compression Staple K111253: Arthrex Distal Extremity Plate System… | 2008 |
| * | K111253 | Arthrex Distal Extremity Plate SystemSummary page 4…K041965: Arthrex Humeral Fracture Plates & Screws K080111: Arthrex Compression Staple K111253: Arthrex Distal Extremity Plate System K130510: Arthrex Compression Plates… | 2011 |
| * | K130510 | Arthrex Compression PlatesSummary page 4…K080111: Arthrex Compression Staple K111253: Arthrex Distal Extremity Plate System K130510: Arthrex Compression Plates K131474: Arthrex Distal Radius Plate System… | 2013 |
| * | K131474 | Arthrex Distal Radius Plate SystemSummary page 4…K111253: Arthrex Distal Extremity Plate System K130510: Arthrex Compression Plates K131474: Arthrex Distal Radius Plate System K132217: Arthrex Compression FT Screws Purpose o… | 2013 |
| * | K132217 | Arthrex Compression FT ScrewsSummary page 4…K130510: Arthrex Compression Plates K131474: Arthrex Distal Radius Plate System K132217: Arthrex Compression FT Screws Purpose of Submission This special 510(k) premarket… | 2013 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 15 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 14 of the 59 ancestors have a recall of any class.
- Of its descendants, K250920 (Arthrex, Inc., 2025) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K014155.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Arthrex Modified Osteotomy System, designed for Opening Wedge Distal Tibial, Distal Femoral, Proximal Tibial osteotomies, and High Tibial Closing Osteotomies, is used in conjunction with bone screws to provide fixation following surgery. Specifically for use in treatment of non-union, malunion, and fractures of proximal tibia, distal femur, and distal tibia including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar…
Read the full statement (411 words)
The Arthrex Modified Osteotomy System, designed for Opening Wedge Distal Tibial, Distal Femoral, Proximal Tibial osteotomies, and High Tibial Closing Osteotomies, is used in conjunction with bone screws to provide fixation following surgery. Specifically for use in treatment of non-union, malunion, and fractures of proximal tibia, distal femur, and distal tibia including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures. Specially sloped plates can be used in cases when a tibial slope adjustment is needed. This system consists of plates and screws which join together to correct abnormalities or trauma related injuries. It is intended to be used with adequate post-operative immobilization.
The Arthrex Humeral Fracture Plates and Screws are intended to provide internal fixation of proximal fractures of the humerus.
The Arthrex Compression Staple is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodesis or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition, and stabilize metatarsus primus varus.
The Arthrex Distal Extremity Plate System is intended for use in stabilization of fresh fractures, revision procedures, osteotomies, joint fusion and reconstruction of small bones and bone fragments of the hand/wrist, foot/ankle, and osteopenic bone.
The Arthrex Compression Plates are intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle, foot, hand and wrist, such as opening wedge osteotomies of Hallux Valgus.
The Arthrex Distal Radius Plate System is intended for internal fixation for fractures and reconstruction of the small bones, primarily including the distal radius and distal ulna. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and malunions. This system can be used for palmar, dorsal or orthogonal application.
The Arthrex Compression FT Screw is intended for fixation of small bone fragments, such as apical fragments, osteochondral fragments and cancellous fragments. Specific applications include the following: Osteochondral fragments (talar vault, femoral condyle); Apical fragments (radial head, patellar rim, navicular, metacarpal/metatarsal); Cancellous fragments (talus); Carpal, metacarpal, and small hand bone; Tarsal and metatarsals; Phalanges; Intra-articular fractures; Ankle; Proximal and distal humerus; Proximal and distal radius; Proximal and distal ulna; Osteochondral fixation and fractures; Osteochondritis Dissecans; Fixation of fractures and osteotomies about the knee; Oblique fractures of the fibula; Reconstructive surgeries of the foot; Malleolar fixation
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150456 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150456: Arthrex Plates, Screws, and Staples.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150456
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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