510(k) · Cleared
ClearedLisfranc Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
New Deal, S.A. · HRS Plate, Fixation, Bone
Cleared on Aug 3, 2006 as substantially equivalent to K033639 (Acumed, LLC, 2004) and 2 other predicates after a 161-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it.
- Decided
- Aug 3, 2006
- Review
- 161 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K000684 (2000). 16 ancestors in all, the oldest K890939 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 3 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 2 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 1 generation backK033639 Acumed Lower Extremity Congruent Plate SystemAcumed, LLC · 2004 · Recalled
- This deviceK060474 Lisfranc PlateNew Deal, S.A. · 2006
- Descendant · cites it directly · 0 of its ownK063820 Lisfranc PlateNew Deal, S.A. · 2007
Most influential descendants
Showing 1 of 1 · See all- K063820Lisfranc PlateNew Deal, S.A. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −3 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −2 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −1 | K033639 | Acumed Lower Extremity Congruent Plate System | Acumed, LLC | 2004 | 10 |
| 0 (this device) | K060474 | Lisfranc Plate | New Deal, S.A. | 2006 | — |
| +1 | K063820 | Lisfranc Plate | New Deal, S.A. | 2007 | — |
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 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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? (3)
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 |
|---|---|---|---|
| * | K033639 | Acumed Lower Extremity Congruent Plate SystemSummary page 1…ation Panel: Orthopedic Substantial Equivalence: The Lisfranc Plate is substantially equivalent to the Acumed Lower Extremity Congruent Bone Plate System, K033639, the Synthes Modular Foot System -2.7 nmn Module, K010321 and the Synthes Modular Foot System, K001941.… | 2004 |
| * | K010321 | Modular Foot System - 2.7 MM ModuleSummary page 1…ranc Plate is substantially equivalent to the Acumed Lower Extremity Congruent Bone Plate System, K033639, the Synthes Modular Foot System -2.7 nmn Module, K010321 and the Synthes Modular Foot System, K001941. 4-001 Device Descripti… | 2001 |
| * | K001941 | Synthes Modular Foot SystemSummary page 1…Acumed Lower Extremity Congruent Bone Plate System, K033639, the Synthes Modular Foot System -2.7 nmn Module, K010321 and the Synthes Modular Foot System, K001941. 4-001 Device Description: The NEWDEAL ® Lisfranc Plate consists of… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063820 | Lisfranc Plate | 2007 | 0 |
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 6 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 6 of the 16 ancestors have a recall of any class.
- Of its descendants, K063820 (New Deal, S.A., 2007) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K033639.
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 NEWDEAL Lisfranc Plates are intended for fractures, fusions, osteotomies and replantations of small bones at the tarsometatarsal joints (Lisfrane joints)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060474 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060474: Lisfranc Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060474
Report an extraction error
Are you the manufacturer?
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