510(k) · Cleared
ClearedIntertan CHS Locking Plate System Prox Fem Plates/Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · JDO Device, Fixation, Proximal Femoral, Implant
Cleared on Apr 10, 2008 as substantially equivalent to K072818 (Smith & Nephew, Inc., 2007) and 5 other predicates after a 51-day review. Its family tree reaches back 4 generations to 1998. 35 later devices descend from it.
- Decided
- Apr 10, 2008
- Review
- 51 days
- Class
- Class II
- Product code
- JDO
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 4 generations to K981372 (1998). 26 ancestors in all, the oldest K813554 (1982). 35 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- 3 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- 2 generations backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
- 1 generation backK072818 Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe…Smith & Nephew, Inc. · 2007
- This deviceK080434 Intertan CHS Locking Plate System Prox Fem Plates/ScrewSmith & Nephew, Inc. · 2008
- Descendant · cites it directly · 34 of its ownK090656 Intertan CHS Limited Collapse Set ScrewSmith & Nephew, Inc. · 2009
- Descendant · cites it directly · 33 of its ownK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
- Descendant · 2 generations on · 32 of its ownK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 14 of its ownK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
- Descendant · 4 generations on · 11 of its ownK173166 ANTHEM Fracture SystemGlobus Medical, Inc. · 2017
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K090656Intertan CHS Limited Collapse Set ScrewSmith & Nephew, Inc. · 2009 · cites it directly34descendants
- K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013 · cites it directly33descendants
- K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · 2 generations on32descendants
- K163361ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017 · 3 generations on14descendants
- K173166ANTHEM Fracture SystemGlobus Medical, Inc. · 2017 · 4 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| −3 | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| −2 | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | Smith & Nephew, Inc. | 2003 | 1 |
| −1 | K072818 | Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe Access | Smith & Nephew, Inc. | 2007 | — |
| 0 (this device) | K080434 | Intertan CHS Locking Plate System Prox Fem Plates/Screw | Smith & Nephew, Inc. | 2008 | — |
| +1 | K090656 | Intertan CHS Limited Collapse Set Screw | Smith & Nephew, Inc. | 2009 | — |
| +1 | K123055 | Smith & Nephew, Inc Screw and Plate System Instrumentation | Smith & Nephew, Inc. | 2013 | — |
| +2 | K140814 | Evos Mini-Fragment Plating System | Smith & Nephew, Inc. | 2014 | 2 |
| +3 | K163361 | ANTHEM™ Fracture System | Globus Medical, Inc. | 2017 | — |
| +4 | K173166 | ANTHEM Fracture System | Globus Medical, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1990 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 7 | 0 |
| 2025 | 7 | 0 |
| 2026 | 3 | 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? (6)
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 |
|---|---|---|---|
| * | K072818 | Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe AccessSummary page 2…ign features, overall indications for use, and material composition. * PERI-LOCTM Periarticular Locked Plating System Proximal Femur Bone Plates and Bone Screws - K072818 * PERI-LOCTM Periarticular Locked Plating System - K033669 * TriGen InterTAN Nail- K040212 · Smith & Nephew Compression Hip… | 2007 |
| * | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)Summary page 2…sition. * PERI-LOCTM Periarticular Locked Plating System Proximal Femur Bone Plates and Bone Screws - K072818 * PERI-LOCTM Periarticular Locked Plating System - K033669 * TriGen InterTAN Nail- K040212 · Smith & Nephew Compression Hip Screw- K993289 * Orthofix Gotfried Pc.C.P.- K983814 * De… | 2003 |
| * | K040212 | Trigen IntertanSummary page 2…lar Locked Plating System Proximal Femur Bone Plates and Bone Screws - K072818 * PERI-LOCTM Periarticular Locked Plating System - K033669 * TriGen InterTAN Nail- K040212 · Smith & Nephew Compression Hip Screw- K993289 * Orthofix Gotfried Pc.C.P.- K983814 * DePuy Ace Captured Hip Screw- K81355… | 2004 |
| * | K993289 | Smith & Nephew Compression Hip Screw System, Intramedullary Hip Screw SystemSummary page 2…es and Bone Screws - K072818 * PERI-LOCTM Periarticular Locked Plating System - K033669 * TriGen InterTAN Nail- K040212 · Smith & Nephew Compression Hip Screw- K993289 * Orthofix Gotfried Pc.C.P.- K983814 * DePuy Ace Captured Hip Screw- K813554… | 1999 |
| * | K983814 | Gotfried Percutaneous Compression Plating SystemSummary page 2…RI-LOCTM Periarticular Locked Plating System - K033669 * TriGen InterTAN Nail- K040212 · Smith & Nephew Compression Hip Screw- K993289 * Orthofix Gotfried Pc.C.P.- K983814 * DePuy Ace Captured Hip Screw- K813554… | 1999 |
| * | K813554 | Ace/Kyle Captured Hip ScrewSummary page 2…em - K033669 * TriGen InterTAN Nail- K040212 · Smith & Nephew Compression Hip Screw- K993289 * Orthofix Gotfried Pc.C.P.- K983814 * DePuy Ace Captured Hip Screw- K813554 Page 2 of2 DEPARTM… | 1982 |
What descends from it? (35)
See all 354 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 10 years and passes through 2 companies; a new generation was cleared every 3.9 years on median.
- 8 of the 26 ancestors have a recall of any class.
- Of its descendants, K090656 (Smith & Nephew, Inc., 2009) has gone furthest, with 34 descendants of its own.
- 9 other devices also cite its predicate K072818.
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?
InterTAN™ CHS Proximal Femur Locking Bone Plates and Bone Screws are indicated for:
1.) Intracapsular fractures of the proximal femur
2.) Intertrochanteric fractures.
3.) Stable and unstable fractures of the proximal femur in which medial cortex stability can be restored.
4.) Hip osteotomy
* For certain high intracapsular fractures, it may be more prudent to select a prosthesis in lieu of internal fixation to reduce the risk of nonunion or AVN of the femoral head.
Components in the InterTAN™ CHS Plating System are for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080434 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080434: Intertan CHS Locking Plate System Prox Fem Plates/Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080434
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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