510(k) · Cleared
Recalled · Class II · 2015Orthopedic Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · JDR Staple, Fixation, Bone
Cleared on Apr 28, 2003 after a 19-day review. The FDA summary names its predicate without a number. 10 later devices descend from it. It has been recalled once.
- Decided
- Apr 28, 2003
- Review
- 19 days
- Class
- Class II
- Product code
- JDR
- Recalls
- 1
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK031127 Orthopedic WireHowmedica Osteonics Corp. · 2003
- Descendant · cites it directly · 8 of its ownK110895 Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited · 2011
- Descendant · 2 generations on · 3 of its ownK163489 OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited · 2017 · Recalled
- Descendant · 2 generations on · 2 of its ownK150889 Suture Wires and Wire LoopsZimmer, Inc. · 2015
- Descendant · 3 generations on · 1 of its ownK203773 BRM TOOL ScrewsBrm Extremities Srl · 2022
- Descendant · 3 generations on · 1 of its ownK151848 Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready…Zimmer, Inc. · 2016
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited · 2011 · cites it directly8descendants
- K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited · 2017 · 2 generations on3descendants
- K150889Suture Wires and Wire LoopsZimmer, Inc. · 2015 · 2 generations on2descendants
- K203773BRM TOOL ScrewsBrm Extremities Srl · 2022 · 3 generations on1descendant
- K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc. · 2016 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031127 | Orthopedic Wire | Howmedica Osteonics Corp. | 2003 | — |
| +1 | K110895 | Ortho Solutions Trauma Implants for Osteosynthesis | Ortho Solutions Limited | 2011 | — |
| +2 | K163489 | OrthoSolutions 'System26' Bone Screws | Ortho Solutions UK Limited | 2017 | 1 |
| +2 | K150889 | Suture Wires and Wire Loops | Zimmer, Inc. | 2015 | — |
| +3 | K203773 | BRM TOOL Screws | Brm Extremities Srl | 2022 | — |
| +3 | K151848 | Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle… | Zimmer, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | — | Orthopedic Wire Named without a submission number |
What descends from it? (10)
2 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 |
|---|---|---|---|---|
| Dec 23, 2015 | Class II | Z-0855-2016 | Under Investigation by firm | The wire packages are correctly marked with a "NON-STERILE" label, however, the enclosed Instructions For Use (IFU) states the device are sterilized via gamma irradiation and should not be resterilized. Since the IFU states the devices… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K110895 (Ortho Solutions Limited, 2011) has gone furthest, with 8 descendants of its own.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 subject orthopedic wires are single-use devices. They are intended for:
Bone fracture fixation,
Osteotomy,
Arthrodesis,
Correction of deformity,
Revision procedures where other treatments or devices have been unsuccessful, and;
Bone reconstruction procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031127 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031127: Orthopedic Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031127
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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