510(k) · Cleared
ClearedOsteoCentric Integrated Hip Fastener System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteocentric Technologies D.B.A. Osteocentric Trauma · JDO Device, Fixation, Proximal Femoral, Implant
Cleared on Apr 30, 2021 as substantially equivalent to K953607 (Synthes (Usa), 1996) and 7 other predicates after a 91-day review. Its family tree reaches back 12 generations to 1996. 1 later device descends from it.
- Decided
- Apr 30, 2021
- Review
- 91 days
- Class
- Class II
- Product code
- JDO
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 12 generations to K962616 (1996). 97 ancestors in all, the oldest K791619 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 8 generations between
- 3 generations backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- 2 generations backK152686 Conquest FNSmith & Nephew · 2016
- 1 generation backK193029 Conquest FNSmith & Nephew, Inc. · 2020
- This deviceK210247 OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma · 2021
- Descendant · cites it directly · 0 of its ownK230764 OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies · 2023
Show all 12 generations
- Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 11 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 10 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 9 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 8 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 7 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 6 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 5 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 4 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 3 generations backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- 2 generations backK152686 Conquest FNSmith & Nephew · 2016
- 1 generation backK193029 Conquest FNSmith & Nephew, Inc. · 2020
- This deviceK210247 OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma · 2021
Most influential descendants
Showing 1 of 1 · See all- K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −11 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −10 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −9 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −8 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −7 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −6 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −5 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −4 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −3 | K111994 | Smith & Nephew Cannulated Screws and Washers | Smith & Nephew, Inc. | 2011 | — |
| −2 | K152686 | Conquest FN | Smith & Nephew | 2016 | — |
| −1 | K193029 | Conquest FN | Smith & Nephew, Inc. | 2020 | — |
| 0 (this device) | K210247 | OsteoCentric Integrated Hip Fastener System | Osteocentric Technologies D.B.A. Osteocentric Trauma | 2021 | — |
| +1 | K230764 | OsteoCentric Integrated Hip Fastener System | OsteoCentric Technologies | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 9 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 7 | 0 |
| 2000 | 11 | 0 |
| 2001 | 8 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 6 | 0 |
| 2005 | 5 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (8)
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 |
|---|---|---|---|
| * | K953607 | Titanium Limited Contact Dynamic Hip Screw Plate (Tilc-DHS)Summary page 5…K210247 Page 2 of 2 510k Number Trade or Proprietary Manufacturer Device Category or Model Name K953607 Dynamic Hip Screw Synthes (USA) Primary K923613, K791619 Dynamic Hip Screw… | 1996 |
| * | K923613 | Synthes Limited Contact-Dynamic Hip Screw ImplantSummary page 5…Manufacturer Device Category or Model Name K953607 Dynamic Hip Screw Synthes (USA) Primary K923613, K791619 Dynamic Hip Screw Synthes (USA) Additional K914546 Angled Blade Plate… | 1993 |
| * | K791619 | Dynamic Hip ScrewSummary page 5…turer Device Category or Model Name K953607 Dynamic Hip Screw Synthes (USA) Primary K923613, K791619 Dynamic Hip Screw Synthes (USA) Additional K914546 Angled Blade Plate Synt… | 1979 |
| * | K914546 | Angled Blade PlateSummary page 5…07 Dynamic Hip Screw Synthes (USA) Primary K923613, K791619 Dynamic Hip Screw Synthes (USA) Additional K914546 Angled Blade Plate Synthes (USA) Additional K193029 Conquest FN… | 1991 |
| * | K193029 | Conquest FNSummary page 5…K791619 Dynamic Hip Screw Synthes (USA) Additional K914546 Angled Blade Plate Synthes (USA) Additional K193029 Conquest FN Smith & Nephew, Inc. Additional K150818 Versa-Fx Femoral… | 2020 |
| * | K150818 | Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral…Summary page 5…Angled Blade Plate Synthes (USA) Additional K193029 Conquest FN Smith & Nephew, Inc. Additional K150818 Versa-Fx Femoral Zimmer, Inc. Additional Fixation System, Versa… | 2015 |
| * | K000972 | Synthes (Usa) Trochanter Stabilization Plate for DHSSummary page 5…ixation System, Versa- Fx II Femoral Fixation System, Free-Lock Femoral Fixation System K000972 Trochanter Stabilization Synthes (USA) Additional Plate for DHS9 K12077… | 2000 |
| * | K120772 | NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button for NCB Oplyaxial…Summary page 5…Femoral Fixation System K000972 Trochanter Stabilization Synthes (USA) Additional Plate for DHS9 K120772 NCB Periprosthetic Zimmer GMBH Additional trochanter Plates and… | 2012 |
| † | K170021 | SMV Scientific Cannulated Screws | 2017 |
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 |
|---|---|---|---|
| K230764 | OsteoCentric Integrated Hip Fastener System | 2023 | 0 |
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 25 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 21 of the 97 ancestors have a recall of any class.
- Of its descendants, K230764 (OsteoCentric Technologies, 2023) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K953607.
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. 2021, 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 OsteoCentric Integrated Hip Fastener System is intended to treat stable and unstable intertrochanteric, subtrochanteric, and basilar neck fractures in which a stable medial buttress can be reconstructed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210247 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210247: OsteoCentric Integrated Hip Fastener System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210247
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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