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 Mar 29, 2007 as substantially equivalent to K051908 (Wrightmedicaltechnologyinc, 2005) and 1 other predicate after a 42-day review. Its family tree reaches back 4 generations to 1997. 102 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 29, 2007
- Review
- 42 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 4 generations to K964226 (1997). 10 ancestors in all, the oldest K895117 (1990). 102 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK964226 Memory Staple (20 Sizes Available)Landos, Inc. · 1997
- 3 generations backK991482 Uni-Clip StapleNew Deal, S.A. · 1999
- 2 generations backK011716 The Uni-Clip StapleNew Deal, S.A. · 2001 · Recalled
- 1 generation backK061594 Large Uni-Clip StapleNew Deal, S.A. · 2006
- This deviceK070447 Newdeal Compression PlateNewdeal Sas · 2007
- Descendant · cites it directly · 98 of its ownK093914 Newdeal Compression PlatesNewdeal Sas · 2011 · Recalled
- Descendant · 2 generations on · 97 of its ownK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
- Descendant · 3 generations on · 95 of its ownK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
- Descendant · 4 generations on · 31 of its ownK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
- Descendant · 4 generations on · 24 of its ownK143025 Total Compression Plating SystemWrightmedicaltechnologyinc · 2014
Showing 5 of 102 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 102 · See all- K093914Newdeal Compression PlatesNewdeal Sas · 2011 · cites it directly98descendants
- K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · 2 generations on97descendants
- K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012 · 3 generations on95descendants
- K140397Paralock Plating System / Tuffnek ScrewParagon 28 · 2014 · 4 generations on31descendants
- K143025Total Compression Plating SystemWrightmedicaltechnologyinc · 2014 · 4 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K964226 | Memory Staple (20 Sizes Available) | Landos, Inc. | 1997 | — |
| −3 | K991482 | Uni-Clip Staple | New Deal, S.A. | 1999 | — |
| −2 | K011716 | The Uni-Clip Staple | New Deal, S.A. | 2001 | 1 |
| −1 | K061594 | Large Uni-Clip Staple | New Deal, S.A. | 2006 | — |
| 0 (this device) | K070447 | Newdeal Compression Plate | Newdeal Sas | 2007 | — |
| +1 | K093914 | Newdeal Compression Plates | Newdeal Sas | 2011 | 5 |
| +2 | K113014 | Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws | Wrightmedicaltechnologyinc | 2012 | 12 |
| +3 | K121651 | Ortholoc 3DI Midfoot/Flatfoot System | Wrightmedicaltechnologyinc | 2012 | — |
| +4 | K140397 | Paralock Plating System / Tuffnek Screw | Paragon 28 | 2014 | — |
| +4 | K143025 | Total Compression Plating System | Wrightmedicaltechnologyinc | 2014 | — |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 6 | 0 |
| 2016 | 4 | 0 |
| 2017 | 10 | 0 |
| 2018 | 5 | 0 |
| 2019 | 6 | 0 |
| 2020 | 13 | 0 |
| 2021 | 9 | 0 |
| 2022 | 6 | 0 |
| 2023 | 11 | 0 |
| 2024 | 11 | 0 |
| 2025 | 7 | 0 |
| 2026 | 7 | 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? (2)
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 |
|---|---|---|---|
| * | K051908 | Charlotte Compression PlateSummary page 1…n Panel: Orthopedic Substantial Equivalence: The Newdeal Compression Plate is substantially equivalent to the Wright Medical Technology Compression Plate, K05 1908 and the Newdeal Large UNI-CLIP Staple, K061594. 2 Newde… | 2005 |
| * | K061594 | Large Uni-Clip StapleSummary page 1…e Newdeal Compression Plate is substantially equivalent to the Wright Medical Technology Compression Plate, K05 1908 and the Newdeal Large UNI-CLIP Staple, K061594. 2 Newdeal SAS… | 2006 |
| † | K011716 | The Uni-Clip Staple | 2001 |
| † | K041601 | Surfix Knee Osteotomy System | 2004 |
| † | K060474 | Lisfranc Plate | 2006 |
| † | K060476 | Lapidus Plate | 2006 |
| † | K060473 | TTC Plate | 2006 |
What descends from it? (102)
See all 1023 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 |
|---|---|---|---|---|
| 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… |
| Sep 30, 2008 | Not classified | Z-0307-2009 | Nonconforming Material/Component | Reports of the Uni-CP Compression Forceps breaking during the Compression of the Uni-CP plate |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K093914 (Newdeal Sas, 2011) has gone furthest, with 98 descendants of its own.
- 4 other devices also cite its predicate K051908.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 indicated for fixation of bone fractures or for bone reconstruction.
Examples include:
- Arthrodesis in hand or foot surgery
- Fractures 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 plate(s) used should be adapted to the specific indication.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070447 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070447: 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/K070447
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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