510(k) · Cleared
Recalled · Class II · 2020TSP Hip Fracture Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · JDO Device, Fixation, Proximal Femoral, Implant
Cleared on Apr 4, 2014 as substantially equivalent to K813554 (Ace Orthopedic Manufacturing Co., 1982) and 4 other predicates after a 91-day review. Its family tree reaches back 4 generations to 1992. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Apr 4, 2014
- Review
- 91 days
- Class
- Class II
- Product code
- JDO
- Recalls
- 2
- Predicates
- 5
Its longest line of descent runs back 4 generations to K922322 (1992). 33 ancestors in all, the oldest K781389 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK922322 Alphatec 3.5MM Znnulated Cortical Lag ScrewAlphatec Mfg., Inc. · 1992
- 3 generations backK013534 Self-Countersinking Bone ScrewBiomet Orthopedics, Inc. · 2001
- 2 generations backK024086 Propeller Head Small Cannulated Screw SystemBiomet Orthopedics, Inc. · 2003
- 1 generation backK082874 Biodrive Cannulated Screw SystemBiomet Trauma · 2009
- This deviceK140018 TSP Hip Fracture Plating SystemBiomet, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK173826 THP Hip Fracture Plating SystemBiomet, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K173826THP Hip Fracture Plating SystemBiomet, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K922322 | Alphatec 3.5MM Znnulated Cortical Lag Screw | Alphatec Mfg., Inc. | 1992 | — |
| −3 | K013534 | Self-Countersinking Bone Screw | Biomet Orthopedics, Inc. | 2001 | — |
| −2 | K024086 | Propeller Head Small Cannulated Screw System | Biomet Orthopedics, Inc. | 2003 | — |
| −1 | K082874 | Biodrive Cannulated Screw System | Biomet Trauma | 2009 | — |
| 0 (this device) | K140018 | TSP Hip Fracture Plating System | Biomet, Inc. | 2014 | — |
| +1 | K173826 | THP Hip Fracture Plating System | Biomet, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K813554 | Ace/Kyle Captured Hip ScrewSummary page 1…appliances and accessories. Product Code(s): JDO, Kfl Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K8 13554 - Ace/Kyle Captured H-ip Screw - Biomlet (Formerly DePuy) K080685 - HipLOC Compression Hip Screw - Biomet K… | 1982 |
| * | K080685 | Hiploc Compression Hip ScrewSummary page 1…JDO, Kfl Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K8 13554 - Ace/Kyle Captured H-ip Screw - Biomlet (Formerly DePuy) K080685 - HipLOC Compression Hip Screw - Biomet K(972629 - TK2 Compression Hip Screw System - Biomiet (Formerly DePuy)… | 2008 |
| * | K972629 | Depuy AE TK2 Hip Screw SystemSummary page 1…alence Is Claimed: K8 13554 - Ace/Kyle Captured H-ip Screw - Biomlet (Formerly DePuy) K080685 - HipLOC Compression Hip Screw - Biomet K(972629 - TK2 Compression Hip Screw System - Biomiet (Formerly DePuy) K(082874 - BioDrive Cannulated Screw System - Biomet… | 1997 |
| * | K082874 | Biodrive Cannulated Screw SystemSummary page 1…Formerly DePuy) K080685 - HipLOC Compression Hip Screw - Biomet K(972629 - TK2 Compression Hip Screw System - Biomiet (Formerly DePuy) K(082874 - BioDrive Cannulated Screw System - Biomet K(092078 - OptiLock Periarticular Plating System - Biomect Device Descrip… | 2009 |
| * | K092078 | Optilock Periarticular PlatingSummary page 1…w - Biomet K(972629 - TK2 Compression Hip Screw System - Biomiet (Formerly DePuy) K(082874 - BioDrive Cannulated Screw System - Biomet K(092078 - OptiLock Periarticular Plating System - Biomect Device Description: The TSP Hip Fracture Plating System consists of a series… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173826 | THP Hip Fracture Plating System | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 7, 2020 | Class II | Z-1347-2020 | Under Investigation by firm | Potential increase in fracture rate was detected during internal testing, in addition to potential discoloration inside the inner pouch of the packaging. |
| Jun 10, 2016 | Class II | Z-2240-2016 | Device Design | The screw may fracture at the junction of the shaft and the head during implantation. The patient may retain a foreign body if the fractured screw cannot be removed. Soft tissue irritation will not occur as the retained portion of the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 6.1 years on median.
- 6 of the 33 ancestors have a recall of any class.
- Of its descendants, K173826 (Biomet, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K813554.
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. 2014, 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?
The Biomet Hip Fracture Plating Systems are indicated for use in the open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures and intertrochanteric fractures. Fracture plates with six or more femoral shaft fixation screw holes are also indicated for subtrochanteric fractures as well as proximal femoral osteotomies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140018 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140018: TSP Hip Fracture Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140018
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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