510(k) · Cleared
ClearedOsteonics FX-Cablelok Grip Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteonics Corp. · LYT Fixation Accessory
Cleared on May 5, 1998 after a 77-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- May 5, 1998
- Review
- 77 days
- Class
- Class II
- Product code
- LYT
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK980594 Osteonics FX-Cablelok Grip ComponentsOsteonics Corp. · 1998
- Descendant · cites it directly · 2 of its ownK984432 Dall-Miles Cable Grip (a-Grip)Howmedica Osteonics Corp. · 1999
- Descendant · 2 generations on · 1 of its ownK043252 Cabling System Trochanter HookSmith & Nephew, Inc. · 2005
- Descendant · 3 generations on · 0 of its ownK123598 Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc. · 2013 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K984432Dall-Miles Cable Grip (a-Grip)Howmedica Osteonics Corp. · 1999 · cites it directly2descendants
- K043252Cabling System Trochanter HookSmith & Nephew, Inc. · 2005 · 2 generations on1descendant
- K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc. · 2013 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980594 | Osteonics FX-Cablelok Grip Components | Osteonics Corp. | 1998 | — |
| +1 | K984432 | Dall-Miles Cable Grip (a-Grip) | Howmedica Osteonics Corp. | 1999 | — |
| +2 | K043252 | Cabling System Trochanter Hook | Smith & Nephew, Inc. | 2005 | — |
| +3 | K123598 | Smith & Nephew, Inc. Hip System Instrumentation | Smith & Nephew, Inc. | 2013 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2005 | 1 | 0 |
| 2013 | 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 LYT? 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? (2)
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 |
|---|---|---|---|
| * | — | Howmedica Dall Miles Cable Grip System and Mini Cleat Named without a submission number | |
| * | — | FX-Cablelok System Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K984432 | Dall-Miles Cable Grip (a-Grip) | 1999 | 2 |
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?
- Of its descendants, K984432 (Howmedica Osteonics Corp., 1999) has gone furthest, with 2 descendants of its own.
How does its category compare?
All LYT devicesLYT Fixation Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LYT
FDA has decided no LYT device since 2007.
Median 510(k) review, days · LYT
Too few LYT 510(k)s in any year since 2007 to give a median.
Recalls per year · LYT
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYT
1in 2025
MAUDE reports naming product code LYT, 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 | — | 3 | 1 |
| 2009 | 0 | — | 0 | 5 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 13 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 1 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Osteonics® FX-Cablelok™ Grip Components are indicated for trochanteric reattachment and are intended for use with the commercially available Osteonics® FX-Cablelok™ System cable and sleeve components to provide fixation of the greater trochanter secondary to osteotomy in total hip replacement arthroplasty, surface replacement arthroplasty or any hip procedure requiring a trochanteric osteotomy.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980594 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980594: Osteonics FX-Cablelok Grip Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980594
Report an extraction error
Are you the manufacturer?
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