510(k) · Cleared
ClearedBiomet Cable System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing, Inc. · JDQ Cerclage, Fixation
Cleared on Oct 23, 2007 as substantially equivalent to K920201 (Sofamor Danek Mfg., Inc., 1992) and 3 other predicates after a 169-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Oct 23, 2007
- Review
- 169 days
- Class
- Class II
- Product code
- JDQ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K920201 (1992). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK920201 Titanium Alloy Songer Cable SystemSofamor Danek Mfg., Inc. · 1992
- This deviceK071271 Biomet Cable SystemBiomet Manufacturing, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920201 | Titanium Alloy Songer Cable System | Sofamor Danek Mfg., Inc. | 1992 | — |
| 0 (this device) | K071271 | Biomet Cable System | Biomet Manufacturing, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 2003 | 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? (4)
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 |
|---|---|---|---|
| * | K920201 | Titanium Alloy Songer Cable SystemSummary page 1…ication Name: Cerriage, Bone Fixation (CFR 888.3010) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Medtronic/Sofamor Danek AtlasT M Cable System, K920201, K925812, K030816; Songer Spinal Cable System, K922952. Device Description: The Biomet® Cable System is available in either titan… | 1992 |
| * | K925812 | Titanium Songer Cable SystemSummary page 1…ame: Cerriage, Bone Fixation (CFR 888.3010) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Medtronic/Sofamor Danek AtlasT M Cable System, K920201, K925812, K030816; Songer Spinal Cable System, K922952. Device Description: The Biomet® Cable System is available in either titanium or st… | 1993 |
| * | K030816 | MSD Cable Reduction SystemSummary page 1…iage, Bone Fixation (CFR 888.3010) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Medtronic/Sofamor Danek AtlasT M Cable System, K920201, K925812, K030816; Songer Spinal Cable System, K922952. Device Description: The Biomet® Cable System is available in either titanium or stainless s… | 2003 |
| * | K922952 | Songer Cable SystemSummary page 1…gally Marketed Devices To Which Substantial Equivalence Is Claimed: Medtronic/Sofamor Danek AtlasT M Cable System, K920201, K925812, K030816; Songer Spinal Cable System, K922952. Device Description: The Biomet® Cable System is available in either titanium or stainless steel, consisting of a flexible, multi… | 1993 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K920201.
How does its category compare?
All JDQ devicesJDQ Cerclage, Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
The Biomet® Cable System is indicated for use whenever a conservative or non-implant surgery is deemed insufficient to improve the medical condition of the patient. The System can be utilized anywhere monofilament wire has been previously indicated. 1. Spinal applications include spinal degenerative surgery, as an adjunct to spinal fusions and sublaminar and intraspinous process wiring for trauma applications. The Biomet® Cable System may also be used…
Read the full statement (139 words)
The Biomet® Cable System is indicated for use whenever a conservative or non-implant surgery is deemed insufficient to improve the medical condition of the patient. The System can be utilized anywhere monofilament wire has been previously indicated.
1. Spinal applications include spinal degenerative surgery, as an adjunct to spinal fusions and sublaminar and intraspinous process wiring for trauma applications. The Biomet® Cable System may also be used with instrumentation involving the correction of scoliotic, kyphotic, and lordotic deformities. The titanium system is compatible with other titanium implants and the stainless steel system with stainless steel implants, wherever "wiring" may help secure the attachment of other implants.
2. Trochanteric reattachment after trochanteric osteotomy, following total hip arthroplasty.
3. Sternotomy indications include the "re-wiring" of sternums following osteotomy.
4. Trauma surgery indications include olecranon, ankle, patella, and some shoulder fracture rewiring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071271 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071271: Biomet Cable System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071271
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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