510(k) · Cleared
Recalled · Class II · 2018Hiploc Compression Hip Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing, Inc. · JDO Device, Fixation, Proximal Femoral, Implant
Cleared on Aug 15, 2008 as substantially equivalent to K781389 (Biomet, Inc., 1978) and 1 other predicate after a 157-day review. Its family tree reaches back 1 generation to 1978. 2 later devices descend from it. It has been recalled 4 times.
- Decided
- Aug 15, 2008
- Review
- 157 days
- Class
- Class II
- Product code
- JDO
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 1 generation to K781389 (1978). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK781389 Biomet Concentric Hex ScrewBiomet, Inc. · 1978
- This deviceK080685 Hiploc Compression Hip ScrewBiomet Manufacturing, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK140018 TSP Hip Fracture Plating SystemBiomet, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 0 of its ownK173826 THP Hip Fracture Plating SystemBiomet, Inc. · 2018
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 |
|---|---|---|---|---|---|
| −1 | K781389 | Biomet Concentric Hex Screw | Biomet, Inc. | 1978 | — |
| 0 (this device) | K080685 | Hiploc Compression Hip Screw | Biomet Manufacturing, Inc. | 2008 | — |
| +1 | K140018 | TSP Hip Fracture Plating System | Biomet, Inc. | 2014 | 2 |
| +2 | K173826 | THP Hip Fracture Plating System | Biomet, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 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 JDO? 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 JDO device
- #1 K213126 Smith & Nephew, Inc. Plates and Screws…score 12.0 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K781389 | Biomet Concentric Hex ScrewSummary page 1…evice, Fixation, Proximal Femoral, Implant 3DO (CFR 888.3030) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Biomet® Compression Hip Screw System, K781389; DHS® System, Synthes, K981757. Device Description: The HipLOC TM Compression Hip Screw is designed as an internal fixation devi… | 1978 |
| * | K981757 | Synthes (Usa) DHS Helix SystemSummary page 1…al, Implant 3DO (CFR 888.3030) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Biomet® Compression Hip Screw System, K781389; DHS® System, Synthes, K981757. Device Description: The HipLOC TM Compression Hip Screw is designed as an internal fixation device to provide alignment and str… | 1998 |
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 |
|---|---|---|---|
| K140018 | TSP Hip Fracture Plating System | 2014 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 9, 2018 | Class II | Z-3264-2018 | Process design | HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel |
| Aug 9, 2018 | Class II | Z-3263-2018 | Process design | HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel |
| Aug 9, 2018 | Class II | Z-3261-2018 | Process design | HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel |
| Aug 9, 2018 | Class II | Z-3262-2018 | Process design | HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K140018 (Biomet, Inc., 2014) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JDO devicesJDO Device, Fixation, Proximal Femoral, Implant: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · JDO
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JDO
Too few JDO 510(k)s in any year since 2007 to give a median.
Recalls per year · JDO
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDO
1in 2025
MAUDE reports naming product code JDO, 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 | 4 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 9 |
| 2013 | 0 | — | 1 | 52 |
| 2014 | 1 | — | 0 | 15 |
| 2015 | 0 | — | 0 | 19 |
| 2016 | 1 | — | 0 | 44 |
| 2017 | 1 | — | 0 | 26 |
| 2018 | 1 | — | 0 | 18 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 1 | — | 0 | 19 |
| 2021 | 1 | — | 0 | 10 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 1 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Indications for the HipLOCTM Compression Hip Screw include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080685 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080685: Hiploc Compression Hip Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080685
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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