510(k) · Cleared
ClearedSuture Wires and Wire Loops
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · JDQ Cerclage, Fixation
Cleared on Jul 1, 2015 as substantially equivalent to K110895 (Ortho Solutions Limited, 2011) after a 90-day review. Its family tree reaches back 9 generations to 1996. 2 later devices descend from it.
- Decided
- Jul 1, 2015
- Review
- 90 days
- Class
- Class II
- Product code
- JDQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K962616 (1996). 93 ancestors in all, the oldest K792022 (1979). 2 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 5 generations between
- 3 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 2 generations backK060156 Straight Plate with Angular Stability & Screw SystemI.T.S. Implantat-Technologie-Systeme GmbH · 2006 · Recalled
- 1 generation backK110895 Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited · 2011
- This deviceK150889 Suture Wires and Wire LoopsZimmer, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK151848 Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready…Zimmer, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK261271 Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc. · 2026
Show all 9 generations
- Root · 9 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 8 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 7 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 6 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 5 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 4 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 3 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 2 generations backK060156 Straight Plate with Angular Stability & Screw SystemI.T.S. Implantat-Technologie-Systeme GmbH · 2006 · Recalled
- 1 generation backK110895 Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited · 2011
- This deviceK150889 Suture Wires and Wire LoopsZimmer, Inc. · 2015
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 |
|---|---|---|---|---|---|
| −9 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −8 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −7 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −6 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −5 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −4 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −3 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −2 | K060156 | Straight Plate with Angular Stability & Screw System | I.T.S. Implantat-Technologie-Systeme GmbH | 2006 | 2 |
| −1 | K110895 | Ortho Solutions Trauma Implants for Osteosynthesis | Ortho Solutions Limited | 2011 | — |
| 0 (this device) | K150889 | Suture Wires and Wire Loops | Zimmer, Inc. | 2015 | — |
| +1 | K151848 | Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle… | Zimmer, Inc. | 2016 | — |
| +2 | K261271 | Cable-Ready® Cable Grip System | Pioneer Surgical Technology, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1981 | 1 | 0 |
| 1989 | 3 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 11 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 10 | 0 |
| 2001 | 7 | 0 |
| 2002 | 5 | 0 |
| 2003 | 5 | 0 |
| 2004 | 5 | 0 |
| 2005 | 5 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 JDQ? 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 JDQ device
- #1 K261271 Cable-Ready® Cable Grip Systemscore 14.7 · 11 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 |
|---|---|---|---|
| * | K110895 | Ortho Solutions Trauma Implants for OsteosynthesisSummary page 4…dics/87 Predicate Device(s): Ortho Solutions Limited, Ortho Solutions Trauma Implants for Osteosynthesis, Cerclage Wires (K110895 – cleared 12/19/2011) Purpose and Device Description: Suture wires and wire loops are used f… | 2011 |
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 |
|---|---|---|---|
| K151848 | Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System | 2016 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 16 of the 93 ancestors have a recall of any class.
- Of its descendants, K151848 (Zimmer, Inc., 2016) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K110895.
How does its category compare?
All JDQ devicesJDQ Cerclage, Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · JDQ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDQ
130in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDQ
5in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDQ
84in 2025
MAUDE reports naming product code JDQ, 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 | 1 | — | 0 | 5 |
| 2008 | 2 | — | 2 | 25 |
| 2009 | 2 | — | 0 | 19 |
| 2010 | 0 | — | 2 | 28 |
| 2011 | 6 | 130 | 0 | 30 |
| 2012 | 3 | 134 | 0 | 130 |
| 2013 | 1 | — | 1 | 321 |
| 2014 | 2 | — | 0 | 223 |
| 2015 | 5 | 92 | 1 | 205 |
| 2016 | 4 | 129 | 0 | 224 |
| 2017 | 1 | — | 0 | 138 |
| 2018 | 6 | 101 | 0 | 182 |
| 2019 | 0 | — | 5 | 158 |
| 2020 | 4 | 93 | 0 | 125 |
| 2021 | 0 | — | 0 | 141 |
| 2022 | 2 | — | 0 | 134 |
| 2023 | 3 | 141 | 0 | 98 |
| 2024 | 3 | 130 | 0 | 115 |
| 2025 | 2 | — | 0 | 84 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Suture wires and wire loops are indicated for use 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/K150889 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150889: Suture Wires and Wire Loops.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150889
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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