510(k) · Cleared
Recalled · 2010Newdeal Compression Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Newdeal Sas · HRS Plate, Fixation, Bone
Cleared on Jun 30, 2009 as substantially equivalent to K070447 (Newdeal Sas, 2007) after a 27-day review. Its family tree reaches back 5 generations to 1997. 2 later devices descend from it. It has been recalled once.
- Decided
- Jun 30, 2009
- Review
- 27 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K964226 (1997). 11 ancestors in all, the oldest K895117 (1990). 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK964226 Memory Staple (20 Sizes Available)Landos, Inc. · 1997
- 4 generations backK991482 Uni-Clip StapleNew Deal, S.A. · 1999
- 3 generations backK011716 The Uni-Clip StapleNew Deal, S.A. · 2001 · Recalled
- 2 generations backK061594 Large Uni-Clip StapleNew Deal, S.A. · 2006
- 1 generation backK070447 Newdeal Compression PlateNewdeal Sas · 2007 · Recalled
- This deviceK091609 Newdeal Compression PlateNewdeal Sas · 2009
- Descendant · cites it directly · 1 of its ownK161303 dynaMX™ Compression PlateMx Orthopedics, Corp. · 2017
- Descendant · 2 generations on · 0 of its ownK193345 Arthrex DynaNite Compression PlateArthrex, Inc. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K964226 | Memory Staple (20 Sizes Available) | Landos, Inc. | 1997 | — |
| −4 | K991482 | Uni-Clip Staple | New Deal, S.A. | 1999 | — |
| −3 | K011716 | The Uni-Clip Staple | New Deal, S.A. | 2001 | 1 |
| −2 | K061594 | Large Uni-Clip Staple | New Deal, S.A. | 2006 | — |
| −1 | K070447 | Newdeal Compression Plate | Newdeal Sas | 2007 | 2 |
| 0 (this device) | K091609 | Newdeal Compression Plate | Newdeal Sas | 2009 | — |
| +1 | K161303 | dynaMX™ Compression Plate | Mx Orthopedics, Corp. | 2017 | — |
| +2 | K193345 | Arthrex DynaNite Compression Plate | Arthrex, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 2000 | 2 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 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? (1)
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 |
|---|---|---|---|
| * | K070447 | Newdeal Compression PlateSummary page 2…Substantial Equivalence: The modified Newdeal Compression Plate is substantially equivalent to commercially marketed device, Newdeal Compression Plate, K070447. Device Description: The Newdeal Compression Plate will offer the combination of two concepts: · By widening the "eye" (diamon… | 2007 |
| † | K011716 | The Uni-Clip Staple | 2001 |
| † | K061594 | Large Uni-Clip Staple | 2006 |
| † | K041601 | Surfix Knee Osteotomy System | 2004 |
| † | K060474 | Lisfranc Plate | 2006 |
| † | K060476 | Lapidus Plate | 2006 |
| † | K060473 | TTC Plate | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161303 | dynaMX™ Compression Plate | 2017 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 18, 2010 | Not classified | Z-0955-2011 | Other | Integra LifeSciences Corporation has decided to initiate a voluntary recall of the Uni-Comp Kits due to inaccurate information relative to the recommended sterilization parameters described in the products Instructions for Use (IFU). The… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K161303 (Mx Orthopedics, Corp., 2017) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K070447.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Newdeal Compression Plate is intended for fixation of bone fractures or for bone
reconstruction.
Examples include:
* Arthrodesis in hand or foot surgery
· Fracture management in the foot or hand
* Mono or Bi-cortical osteotomies in the foot or hand
. Distal or proximal metatarsal or metacarpal osteotomies
* Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc)
The size and number of the plate(s) used should be adapted to the specific indication.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091609 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091609: Newdeal Compression Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091609
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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