510(k) · Cleared
ClearedOsse-Lign
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osseus, LLC · JDQ Cerclage, Fixation
Cleared on Mar 11, 2003 as substantially equivalent to K982545 (Biomet, Inc., 1998) and 3 other predicates after a 139-day review. Its family tree reaches back 4 generations to 1985.
- Decided
- Mar 11, 2003
- Review
- 139 days
- Class
- Class II
- Product code
- JDQ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K844068 (1985). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK844068 Trochanter Cable Grip SystemHowmedica Corp. · 1985
- 3 generations backK961569 Dall-Miles Stainless Steel Beaded CableHowmedica Corp. · 1996
- 2 generations backK971741 Dall-Miles Homogeneous Stainless Steel Cable and Beaded CableHowmedica Corp. · 1997
- 1 generation backK982545 BMP Cable SystemBiomet, Inc. · 1998 · Recalled
- This deviceK023564 Osse-LignOsseus, LLC · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K844068 | Trochanter Cable Grip System | Howmedica Corp. | 1985 | — |
| −3 | K961569 | Dall-Miles Stainless Steel Beaded Cable | Howmedica Corp. | 1996 | — |
| −2 | K971741 | Dall-Miles Homogeneous Stainless Steel Cable and Beaded Cable | Howmedica Corp. | 1997 | — |
| −1 | K982545 | BMP Cable System | Biomet, Inc. | 1998 | 1 |
| 0 (this device) | K023564 | Osse-Lign | Osseus, LLC | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 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? (5)
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 |
|---|---|---|---|
| * | K982545 | BMP Cable SystemSummary page 5…System is based on the equivalence in intended use, materials, operational principals, and indications and contraindications to: BMPTMCable System by Biomet (K982545) Dall-MilesTMCerclage System by Howmedica (K97 174I, K96 1569) SDB Cerclage System by Pioneer Laboratories… | 1998 |
| * | K971741 | Dall-Miles Homogeneous Stainless Steel Cable and Beaded Cable | 1997 |
| * | K961569 | Dall-Miles Stainless Steel Beaded CableSummary page 5…nal principals, and indications and contraindications to: BMPTMCable System by Biomet (K982545) Dall-MilesTMCerclage System by Howmedica (K97 174I, K96 1569) SDB Cerclage System by Pioneer Laboratories (K9926 16) Stainless Steel Cerclage Wire manufactured prior to… | 1996 |
| * | K992616 | SDB Cerclage SystemSummary page 5…BMPTMCable System by Biomet (K982545) Dall-MilesTMCerclage System by Howmedica (K97 174I, K96 1569) SDB Cerclage System by Pioneer Laboratories (K9926 16) Stainless Steel Cerclage Wire manufactured prior to 1976 Page 18 of 183 ===… | 1999 |
| * | — | Stainless Steel Cerclage Wire manufactured prior to 1976 Named without a submission number |
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?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- 3 of the 17 ancestors have a recall of any class.
- 6 other devices also cite its predicate K982545.
How does its category compare?
All JDQ devicesJDQ Cerclage, Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Osse-Lign System is indicated for general orthopedic repairs. This includes such procedures as long bone fractures, bone grafting and reinforcement of bone. This system may also be used for supplementary fixation and reduction with approved bone plates, screws, pins, nails and bone grafting material. Long Bone Fractures Femur fractures Tibia fractures Humerus fractures Joint Fractures Ankle fractures Knee Fractures Hip Fractures Shoulder Fractures…
Read the full statement (104 words)
The Osse-Lign System is indicated for general orthopedic repairs. This includes such procedures as long bone fractures, bone grafting and reinforcement of bone. This system may also be used for supplementary fixation and reduction with approved bone plates, screws, pins, nails and bone grafting material.
Long Bone Fractures
Femur fractures
Tibia fractures
Humerus fractures
Joint Fractures
Ankle fractures
Knee Fractures
Hip Fractures
Shoulder Fractures
Elbow Fractures
Other bone fractures
Olecranon
Pelvis fractures
Patella fractures
Acetabular fractures
Trocanterk reattachment
Fixation of fractures in conjunction with I/M nailing and plating techniques
Stabilization of cortical onlay strut graft
Temporary reduction techniques for OFUF (Open Reduction Internal Fixation)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023564 · printed Nov 5, 2026
Cite this page
510(k) Report. “K023564: Osse-Lign.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023564
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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