510(k) · Cleared
Recalled · 2008Acumed Lower Extremity Congruent Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acumed, LLC · HWC Screw, Fixation, Bone
Cleared on Jan 15, 2004 as substantially equivalent to K012655 (Acu Med, Inc., 2001) and 5 other predicates after a 56-day review. Its family tree reaches back 3 generations to 2000. 98 later devices descend from it. It has been recalled 10 times.
- Decided
- Jan 15, 2004
- Review
- 56 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 10
- Predicates
- 6
Its longest line of descent runs back 3 generations to K000684 (2000). 14 ancestors in all, the oldest K890939 (1989). 98 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 2 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 1 generation backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- This deviceK033639 Acumed Lower Extremity Congruent Plate SystemAcumed, LLC · 2004
- Descendant · cites it directly · 73 of its ownK073375 Newdeal Tibiaxys SystemNewdeal Sas · 2008 · Recalled
- Descendant · 2 generations on · 69 of its ownK110670 VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc…Smith & Nephew, Inc. · 2011
- Descendant · 2 generations on · 56 of its ownK100176 Ascension Ankle Fusion Plate SystemAscension Orthopedics, Inc. · 2010
- Descendant · 2 generations on · 53 of its ownK121425 Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc · 2012
- Descendant · 3 generations on · 31 of its ownK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
Showing 5 of 98 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 98 · See all- K073375Newdeal Tibiaxys SystemNewdeal Sas · 2008 · cites it directly73descendants
- K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc. · 2011 · 2 generations on69descendants
- K100176Ascension Ankle Fusion Plate SystemAscension Orthopedics, Inc. · 2010 · 2 generations on56descendants
- K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc · 2012 · 2 generations on53descendants
- K140397Paralock Plating System / Tuffnek ScrewParagon 28 · 2014 · 3 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −2 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −1 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| 0 (this device) | K033639 | Acumed Lower Extremity Congruent Plate System | Acumed, LLC | 2004 | — |
| +1 | K073375 | Newdeal Tibiaxys System | Newdeal Sas | 2008 | 2 |
| +2 | K110670 | VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone… | Smith & Nephew, Inc. | 2011 | — |
| +2 | K100176 | Ascension Ankle Fusion Plate System | Ascension Orthopedics, Inc. | 2010 | — |
| +2 | K121425 | Ortholoc 3DI Ankle Fusion Plating System | Wrightmedicaltechnologyinc | 2012 | — |
| +3 | K140397 | Paralock Plating System / Tuffnek Screw | Paragon 28 | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1998 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 9 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 8 | 0 |
| 2021 | 11 | 0 |
| 2022 | 2 | 0 |
| 2023 | 14 | 0 |
| 2024 | 8 | 0 |
| 2025 | 8 | 0 |
| 2026 | 12 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 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 |
|---|---|---|---|
| * | K012655 | Congruent Bone Plate SystemSummary page 1…Class II, 21 CFR 888.3030 Device Product Code: HRS Legally Marketed Equivalent Device(s): Acumed LLC Congruent Bone Plate System K012655 Synthes USA Modular Foot System KOO 1941… | 2001 |
| * | K001941 | Synthes Modular Foot System | 2000 |
| * | K974537 | Synthes Cannulated Angle Blade Plate (Cabp) SystemSummary page 1…Synthes USA Modular Foot System KOO 1941 Synthes USA Cannulated Angle Blade Plate System K974537 Depuy Ace Medical Co. Timax Pilon System K982347… | 1998 |
| * | K982347 | Depuy Ace Timax Pilon PlateSummary page 1…Synthes USA Cannulated Angle Blade Plate System K974537 Depuy Ace Medical Co. Timax Pilon System K982347 Synthes USA Calcaneal Plate K020401 Depuy… | 1998 |
| * | K020401 | Synthes Calcaneal PlateSummary page 1…4537 Depuy Ace Medical Co. Timax Pilon System K982347 Synthes USA Calcaneal Plate K020401 Depuy Ace Medical Co. Timax Calcaneal Peri-Articular Plate… | 2002 |
| * | K981775 | Depuy Ace Timax Calcaneal Peri-Articular PlateSummary page 1…alcaneal Plate K020401 Depuy Ace Medical Co. Timax Calcaneal Peri-Articular Plate K981775 Device Description: The Acumed Lower Extremity Congruent Plate System consists of bone plates and screws for fractures, fusions,… | 1998 |
What descends from it? (98)
See all 986 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 14, 2008 | Not classified | Z-2111-2008 | Packaging process control | Product sterility may be compromised. |
| Feb 14, 2008 | Not classified | Z-2114-2008 | Packaging process control | Product sterility may be compromised. |
| Feb 14, 2008 | Not classified | Z-2115-2008 | Packaging process control | Product sterility may be compromised. |
| Feb 14, 2008 | Not classified | Z-2108-2008 | Packaging process control | Product sterility may be compromised. |
| Feb 14, 2008 | Not classified | Z-2113-2008 | Packaging process control | Product sterility may be compromised. |
| Feb 14, 2008 | Not classified | Z-2117-2008 | Packaging process control | Product sterility may be compromised. |
| Feb 14, 2008 | Not classified | Z-2116-2008 | Packaging process control | Product sterility may be compromised. |
| Feb 14, 2008 | Not classified | Z-2112-2008 | Packaging process control | Product sterility may be compromised. |
| Feb 14, 2008 | Not classified | Z-2110-2008 | Packaging process control | Product sterility may be compromised. |
| Feb 14, 2008 | Not classified | Z-2109-2008 | Packaging process control | Product sterility may be compromised. |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 14 ancestors have a recall of any class.
- Of its descendants, K073375 (Newdeal Sas, 2008) has gone furthest, with 73 descendants of its own.
- 27 other devices also cite its predicate K012655.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The Acumed Lower Extremity Congruent Plate System provides fixation during fractures,
fusions, and osteotomies for the phalanges, metatarsals, tarsals, tibia and fibula.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033639 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033639: Acumed Lower Extremity Congruent 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/K033639
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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