510(k) · Cleared
Recalled · Class II · 2018Newdeal Compression Plates
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 Apr 14, 2011 as substantially equivalent to K070447 (Newdeal Sas, 2007) after a 478-day review. Its family tree reaches back 5 generations to 1997. 98 later devices descend from it. It has been recalled 5 times.
- Decided
- Apr 14, 2011
- Review
- 478 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 5 generations to K964226 (1997). 11 ancestors in all, the oldest K895117 (1990). 98 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 deviceK093914 Newdeal Compression PlatesNewdeal Sas · 2011
- Descendant · cites it directly · 97 of its ownK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
- Descendant · 2 generations on · 95 of its ownK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
- Descendant · 3 generations on · 31 of its ownK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
- Descendant · 3 generations on · 24 of its ownK143025 Total Compression Plating SystemWrightmedicaltechnologyinc · 2014
- Descendant · 3 generations on · 23 of its ownK151442 Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc · 2015
Showing 5 of 98 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 98 · See all- K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · cites it directly97descendants
- K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012 · 2 generations on95descendants
- K140397Paralock Plating System / Tuffnek ScrewParagon 28 · 2014 · 3 generations on31descendants
- K143025Total Compression Plating SystemWrightmedicaltechnologyinc · 2014 · 3 generations on24descendants
- K151442Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc · 2015 · 3 generations on23descendants
View 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) | K093914 | Newdeal Compression Plates | Newdeal Sas | 2011 | — |
| +1 | K113014 | Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws | Wrightmedicaltechnologyinc | 2012 | 12 |
| +2 | K121651 | Ortholoc 3DI Midfoot/Flatfoot System | Wrightmedicaltechnologyinc | 2012 | — |
| +3 | K140397 | Paralock Plating System / Tuffnek Screw | Paragon 28 | 2014 | — |
| +3 | K143025 | Total Compression Plating System | Wrightmedicaltechnologyinc | 2014 | — |
| +3 | K151442 | Total Compression Plating (TCP) System | Wrightmedicaltechnologyinc | 2015 | — |
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 |
|---|---|---|
| 2012 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 6 | 0 |
| 2016 | 4 | 0 |
| 2017 | 9 | 0 |
| 2018 | 5 | 0 |
| 2019 | 6 | 0 |
| 2020 | 12 | 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? (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…rthopedic Substantial Equivalence: The modified Newdeal Compression Plates are substantially equivalent to the commercially marketed device, Newdeal Compression Plates, K070447, cleared on March 29, 2007. Device Description: The Newdeal Compression Plates will offer the combination of two concepts: *… | 2007 |
What descends from it? (98)
See all 981 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113014 | Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws | 2012 | 97 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 22, 2018 | Class II | Z-2446-2018 | Packaging change control | Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal. |
| May 22, 2018 | Class II | Z-2443-2018 | Packaging change control | Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal. |
| May 22, 2018 | Class II | Z-2447-2018 | Packaging change control | Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal. |
| May 22, 2018 | Class II | Z-2444-2018 | Packaging change control | Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal. |
| May 22, 2018 | Class II | Z-2445-2018 | Packaging change control | Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 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, K113014 (Wrightmedicaltechnologyinc, 2012) has gone furthest, with 97 descendants 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. 2011, 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 Plates are 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 Newdeal Uni-C PTM U-Plate is intended for arthrodesis of the second and third cuneo-metatarsal and the inter-cuneiform second and third joints.
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/K093914 · printed Nov 5, 2026
Cite this page
510(k) Report. “K093914: Newdeal Compression Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K093914
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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