510(k) · Cleared
Recalled · Class II · 2022DePuy Synthes Hammertoe Continuous Compression Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (USA) Products, LLC · JDR Staple, Fixation, Bone
Cleared on Feb 26, 2020 as substantially equivalent to K993714 (Biomedical Ent., Inc., 2000) and 1 other predicate after a 268-day review. Its family tree reaches back 5 generations to 1996. It has been recalled 2 times.
- Decided
- Feb 26, 2020
- Review
- 268 days
- Class
- Class II
- Product code
- JDR
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 5 generations to K960385 (1996). 10 ancestors in all, the oldest K902307 (1990). No later device cites it as a predicate yet.
- Root · 5 generations backK960385 Sterile Kirschner Wires and Steinmann PinsDepuy, Inc. · 1996
- 4 generations backK022599 Newdeal K WireNew Deal, S.A. · 2002
- 3 generations backK070598 Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseMemometal Technologies · 2007
- 2 generations backK131640 Smooth or Threaded Metallic Bone FastenerBiomedical Ent., Inc. · 2013
- 1 generation backK133520 Hammerlock 2Biomedical Enterprises, Inc. · 2014
- This deviceK191463 DePuy Synthes Hammertoe Continuous Compression ImplantSynthes (USA) Products, LLC · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K960385 | Sterile Kirschner Wires and Steinmann Pins | Depuy, Inc. | 1996 | — |
| −4 | K022599 | Newdeal K Wire | New Deal, S.A. | 2002 | — |
| −3 | K070598 | Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse | Memometal Technologies | 2007 | — |
| −2 | K131640 | Smooth or Threaded Metallic Bone Fastener | Biomedical Ent., Inc. | 2013 | — |
| −1 | K133520 | Hammerlock 2 | Biomedical Enterprises, Inc. | 2014 | — |
| 0 (this device) | K191463 | DePuy Synthes Hammertoe Continuous Compression Implant | Synthes (USA) Products, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2010 | 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 JDR? 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 JDR device
- #1 K243658 TMC Compression Implant Systemscore 16.7 · 18 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 |
|---|---|---|---|
| * | K993714 | Memograph Staple, Warm SystemSummary page 4…: 21 CFR 888.3030 Product Code: JDR Primary Predicate Device: BioMedical Enterprises, Inc. OSStaple (K993714) Predicate Devices Secondary Predicate Device: BioMedical Enterprises, Inc. Hammer… | 2000 |
| * | K133520 | Hammerlock 2Summary page 4…terprises, Inc. OSStaple (K993714) Predicate Devices Secondary Predicate Device: BioMedical Enterprises, Inc. Hammerlock 2(K133520) The implants of the DePuy Synthes Hammertoe Continuous Compression Implant System… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 27, 2022 | Class II | Z-0101-2023 | Error in labeling | The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is… |
| Aug 30, 2022 | Class II | Z-0008-2023 | Employee error | Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a packaging error, result in a surgical delay and may cause soft tissue damage if a larger incision is required to accommodate an alternative form… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 6 companies; a new generation was cleared every 6.1 years on median.
- 1 of the 10 ancestors has a recall of any class.
- 17 other devices also cite its predicate K993714.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · JDR
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDR
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDR
11in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDR
314in 2025
MAUDE reports naming product code JDR, 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 | 8 | 70 | 0 | 3 |
| 2008 | 5 | 89 | 1 | 14 |
| 2009 | 0 | — | 0 | 10 |
| 2010 | 2 | — | 0 | 35 |
| 2011 | 1 | — | 0 | 62 |
| 2012 | 1 | — | 0 | 34 |
| 2013 | 9 | 137 | 0 | 27 |
| 2014 | 11 | 97 | 0 | 49 |
| 2015 | 7 | 111 | 1 | 48 |
| 2016 | 6 | 101 | 0 | 76 |
| 2017 | 9 | 172 | 0 | 116 |
| 2018 | 8 | 107 | 1 | 239 |
| 2019 | 5 | 149 | 0 | 242 |
| 2020 | 4 | 161 | 1 | 234 |
| 2021 | 3 | 62 | 0 | 210 |
| 2022 | 5 | 107 | 11 | 202 |
| 2023 | 9 | 72 | 0 | 175 |
| 2024 | 4 | 29 | 0 | 206 |
| 2025 | 3 | 65 | 0 | 314 |
| 2026 | 2 | — | 2 | — |
What is it indicated for?
The DePuy Synthes Hammertoe Continuous Compression Implant is indicated for small bone reconstruction and fusion of the phalanges in the toes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191463 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191463: DePuy Synthes Hammertoe Continuous Compression Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191463
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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