510(k) · Cleared
ClearedOsteo-Cable Sleeve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · HXN Applier, Cerclage
Cleared on Jan 23, 2003 as substantially equivalent to K982545 (Biomet, Inc., 1998) after a 49-day review. Its family tree reaches back 4 generations to 1985.
- Decided
- Jan 23, 2003
- Review
- 49 days
- Class
- Class I
- Product code
- HXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K844068 (1985). 15 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 deviceK024022 Osteo-Cable SleeveBiomet, Inc. · 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) | K024022 | Osteo-Cable Sleeve | Biomet, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 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 HXN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K982545 | BMP Cable SystemSummary page 1…on, Bone (888.3040) Device Product Code: 87HWC Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Biomet's BMPTMCable System (K982545) Indications for Use: The Cable Sleeve is indicated for general orthopedic repairs, such as: 0 Femur and Tibial Fractures… | 1998 |
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 2 companies; a new generation was cleared every 4.3 years on median.
- 2 of the 15 ancestors have a recall of any class.
- 6 other devices also cite its predicate K982545.
How does its category compare?
All HXN devicesHXN Applier, Cerclage: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HXN
FDA has decided no HXN device since 2007.
Median 510(k) review, days · HXN
Too few HXN 510(k)s in any year since 2007 to give a median.
Recalls per year · HXN
No recall names HXN since 2007.
Adverse event reports per year · HXN
1in 2018
MAUDE reports naming product code HXN, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Osteo-cable Sleeve is indicated for general orthopedic repairs, such as:
Femur And Tibial Fractures
Prophylactic Banding
Trochanteric Reattachment
Olecranon Fractures
Patella Fractures
Ankle Fractures
Fixation Of Spiral Fractures In Conjunction With I/M Nailing And Screwing Techniques
Sternum Fixation After Open Heart Surgery
Stabilization Of Cortical Onlay Strut Graft
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024022 · printed Nov 4, 2026
Cite this page
510(k) Report. “K024022: Osteo-Cable Sleeve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K024022
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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