510(k) · Cleared
Recalled · 2010Congruent Bone Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acu Med, Inc. · HRS Plate, Fixation, Bone
Cleared on Nov 7, 2001 as substantially equivalent to K890939 (Howmedica Corp., 1989) and 5 other predicates after an 86-day review. Its family tree reaches back 2 generations to 2000. 1 of the 800 devices in its family, counting itself, has a Class I recall. 792 later devices descend from it. It has been recalled 16 times.
- Decided
- Nov 7, 2001
- Review
- 86 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 16
- Predicates
- 6
Its longest line of descent runs back 2 generations to K000684 (2000). 7 ancestors in all, the oldest K890939 (1989). 792 later devices descend from it, 28 citing it directly. 1 of the 800 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 1 generation backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- This deviceK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001
- Descendant · cites it directly · 584 of its ownK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- Descendant · 2 generations on · 495 of its ownK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- Descendant · 3 generations on · 487 of its ownK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- Descendant · cites it directly · 280 of its ownK021626 Hallu PlatesNew Deal, S.A. · 2002
- Descendant · cites it directly · 249 of its ownK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
Showing 5 of 792 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub7 generations on · 2021
Most influential descendants
Showing 5 of 792 · See all- K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc. · 2005 · cites it directly584descendants
- K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007 · 2 generations on495descendants
- K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009 · 3 generations on487descendants
- K021626Hallu PlatesNew Deal, S.A. · 2002 · cites it directly280descendants
- K040907Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004 · cites it directly249descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −1 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| 0 (this device) | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | — |
| +1 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| +2 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| +3 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| +1 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| +1 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 9 | 0 |
| 2006 | 8 | 0 |
| 2007 | 6 | 0 |
| 2008 | 4 | 0 |
| 2009 | 7 | 0 |
| 2010 | 10 | 0 |
| 2011 | 21 | 0 |
| 2012 | 21 | 0 |
| 2013 | 24 | 0 |
| 2014 | 40 | 0 |
| 2015 | 43 | 0 |
| 2016 | 27 | 0 |
| 2017 | 62 | 0 |
| 2018 | 31 | 0 |
| 2019 | 41 | 0 |
| 2020 | 50 | 0 |
| 2021 | 52 | 1 |
| 2022 | 48 | 0 |
| 2023 | 56 | 0 |
| 2024 | 74 | 0 |
| 2025 | 70 | 0 |
| 2026 | 83 | 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.
1 device in this family has a Class I recall. 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? (6)
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 |
|---|---|---|---|
| * | K890939 | Dupont Distal Humeral NailSummary page 1…I Substantial Equivalence: The Acumed Congruent Bone Plate System is similar in indication, intended use, material, design, and size to Howmedica’s Distal Humeral Plate (K890939) and Luhr Fixation System (K951415), to Synthes’ Curved Reconstruction Plate (K011334), the Modular Foot System (K001941), and th… | 1989 |
| * | K951415 | Luhr Pan Fixation System Condensed Straight Plate, Y Plates and 1.5MM Bone ScrewSummary page 1…ed Congruent Bone Plate System is similar in indication, intended use, material, design, and size to Howmedica’s Distal Humeral Plate (K890939) and Luhr Fixation System (K951415), to Synthes’ Curved Reconstruction Plate (K011334), the Modular Foot System (K001941), and the One-Third Tubular Plate (K011335)… | 1995 |
| * | K011334 | Synthes Curved Reconstruction PlateSummary page 1…tion, intended use, material, design, and size to Howmedica’s Distal Humeral Plate (K890939) and Luhr Fixation System (K951415), to Synthes’ Curved Reconstruction Plate (K011334), the Modular Foot System (K001941), and the One-Third Tubular Plate (K011335), and to Link’s May Tibia Bone Plates (K912936). Li… | 2001 |
| * | K001941 | Synthes Modular Foot SystemSummary page 1…n, and size to Howmedica’s Distal Humeral Plate (K890939) and Luhr Fixation System (K951415), to Synthes’ Curved Reconstruction Plate (K011334), the Modular Foot System (K001941), and the One-Third Tubular Plate (K011335), and to Link’s May Tibia Bone Plates (K912936). Literature on these predicate devices… | 2000 |
| * | K011335 | Synths One-Third Tubular DCL PlateSummary page 1…late (K890939) and Luhr Fixation System (K951415), to Synthes’ Curved Reconstruction Plate (K011334), the Modular Foot System (K001941), and the One-Third Tubular Plate (K011335), and to Link’s May Tibia Bone Plates (K912936). Literature on these predicate devices is included in Appendix IV. The Congruent… | 2001 |
| * | K912936 | May Humerus PlatesSummary page 1…5), to Synthes’ Curved Reconstruction Plate (K011334), the Modular Foot System (K001941), and the One-Third Tubular Plate (K011335), and to Link’s May Tibia Bone Plates (K912936). Literature on these predicate devices is included in Appendix IV. The Congruent Bone Plate System consists of bone plates and… | 1991 |
What descends from it? (792)
See all 79228 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | 2005 | 584 |
| K021626 | Hallu Plates | 2002 | 280 |
| K040907 | Arthrex Small Fragment Plates and Screws | 2004 | 249 |
| K021321 | Wrist Fusion Plate | 2002 | 113 |
| K033639 | Acumed Lower Extremity Congruent Plate System | 2004 | 98 |
| K102998 | Congruent Bone Plate System | 2011 | 91 |
| K112111 | Acu-Sinch Repair System and Acumed Suture Anchor | 2011 | 49 |
| K050852 | Claviculaplate with Angular Stablity Bone Plate System | 2005 | 38 |
| K071715 | Acumed Congruent Bone Plate System | 2007 | 34 |
| K060156 | Straight Plate with Angular Stability & Screw System | 2006 | 27 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 14, 2010 | Not classified | Z-1807-2010 | Other | The saw blades may not cut aggressively enough for their intended application therefore creating a risk that the saw could generate excessive heat, which may contribute to bone necrosis and/or non-union. |
| Feb 14, 2008 | Not classified | Z-2129-2008 | Packaging process control | Product sterility may be compromised. |
| Feb 14, 2008 | Not classified | Z-2132-2008 | Packaging process control | Product sterility may be compromised. |
| Feb 14, 2008 | Not classified | Z-2128-2008 | Packaging process control | Product sterility may be compromised. |
| Feb 14, 2008 | Not classified | Z-2126-2008 | Packaging process control | Product sterility may be compromised. |
| Feb 14, 2008 | Not classified | Z-2123-2008 | Packaging process control | Product sterility may be compromised. |
| Feb 14, 2008 | Not classified | Z-2124-2008 | Packaging process control | Product sterility may be compromised. |
| Feb 14, 2008 | Not classified | Z-2120-2008 | Packaging process control | Product sterility may be compromised. |
| Feb 14, 2008 | Not classified | Z-2130-2008 | Packaging process control | Product sterility may be compromised. |
| Feb 14, 2008 | Not classified | Z-2121-2008 | Packaging process control | Product sterility may be compromised. |
| Feb 14, 2008 | Not classified | Z-2125-2008 | Packaging process control | Product sterility may be compromised. |
| Feb 14, 2008 | Not classified | Z-2122-2008 | Packaging process control | Product sterility may be compromised. |
| Feb 14, 2008 | Not classified | Z-2131-2008 | Packaging process control | Product sterility may be compromised. |
| Feb 14, 2008 | Not classified | Z-2127-2008 | Packaging process control | Product sterility may be compromised. |
| Jul 9, 2007 | Not classified | Z-2135-2008 | Packaging process control | Product mislabeled. The inner sticky labels for the patient identified the product incorrectly as a Cortical screw (non-locking). The product package was labeled correctly. |
| Jun 29, 2007 | Not classified | Z-2153-2008 | Process control | Plates are incorrectly laser marked. The PL-DR50L plates are incorrectly laser marked with PL-DR70L. |
The 5 latest of 16 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 1 year and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K051735 (Smith & Nephew, Inc., 2005) has gone furthest, with 584 descendants of its own.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Acumed Congruent Bone Plate System provides fixation for fractures, fusions, or osteotomies for the clavicle, humerus, radius, ulna, metacarpal, metatarsal, malleolus, tibia, and fibula.
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/K012655 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012655: Congruent Bone Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012655
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026