510(k) Report

510(k) · Cleared

Cleared

Conquest FN

K193029510(k) TraditionalCleared Feb 28, 2020121-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Smith & Nephew, Inc. · JDO Device, Fixation, Proximal Femoral, Implant

Cleared on Feb 28, 2020 as substantially equivalent to K152686 (Smith & Nephew, 2016) and 1 other predicate after a 121-day review. Its family tree reaches back 11 generations to 1996. 10 later devices descend from it.

Decided
Feb 28, 2020
Review
121 days
Class
Class II
Product code
JDO
Recalls
None
Predicates
2

Its longest line of descent runs back 11 generations to K962616 (1996). 74 ancestors in all, the oldest K792022 (1979). 10 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 2 other ancestors2008: 2 other ancestors2007: 2 other ancestors2005: 5 other ancestors2002: 4 other ancestors2001: 7 other ancestors2006: 4 other ancestors2003: 2 other ancestors1996: 6 other ancestors1995: 2 other ancestors1979: 1 other ancestor2004: 4 other ancestors2000: 7 other ancestors1999: 5 other ancestors1998: 3 other ancestors1990: 1 other ancestor1994: 2 other ancestors1993: 2 other ancestors1991: 1 other ancestor1989: 1 other ancestor2022: 1 descendant cleared2021: 2 descendants cleared2023: 3 descendants cleared2025: 2 descendants cleared2026: 2 descendants clearedK962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998×3: 3 generations cleared close together, K023007 (2002), K030198 (2003), K032705 (2003) ×2: 2 generations cleared close together, K050932 (2005), K051735 (2005) K071563 · Peri-Loc Periarticular Locked Plating System · Smith & Nephew, Inc. · 2007K090675 · Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories · Smith & Nephew, Inc. · 2009K111994 · Smith & Nephew Cannulated Screws and Washers · Smith & Nephew, Inc. · 2011K152686 · Conquest FN · Smith & Nephew · 201619801990200020102020
  1. Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 7 generations between
  3. 3 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  4. 2 generations backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
  5. 1 generation backK152686 Conquest FNSmith & Nephew · 2016
  6. This deviceK193029 Conquest FNSmith & Nephew, Inc. · 2020
  7. Descendant · cites it directly · 7 of its ownK210837 Smith & Nephew Plates and ScrewsSmith & Nephew, Inc. · 2021 · Recalled
  8. Descendant · cites it directly · 2 of its ownK213126 Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc…Smith & Nephew, Inc. · 2022 · Recalled
  9. Descendant · 2 generations on · 1 of its ownK233017 TM Plating SystemTyber Medical, LLC · 2023
  10. Descendant · cites it directly · 1 of its ownK210247 OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma · 2021
  11. Descendant · 3 generations on · 0 of its ownK261207 Exalta Proximal Tibia Plating SystemTyber Medical, LLC · 2026
Show all 11 generations
  1. Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 10 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 9 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 8 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 7 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 6 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 5 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  8. 4 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
  9. 3 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  10. 2 generations backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
  11. 1 generation backK152686 Conquest FNSmith & Nephew · 2016
  12. This deviceK193029 Conquest FNSmith & Nephew, Inc. · 2020

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2021: 22022: 12023: 32025: 22026: 2
2021high 3 (2023) · low 0 (2024)2026

Most influential descendants

Showing 5 of 10 · See all
  • K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc. · 2021 · cites it directly7descendants
  • K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc. · 2022 · cites it directly2descendants
  • K233017TM Plating SystemTyber Medical, LLC · 2023 · 2 generations on1descendant
  • K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma · 2021 · cites it directly1descendant
  • K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC · 2026 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−10K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−9K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−8K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−7K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−6K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
−5K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—
−4K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007—
−3K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009—
−2K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011—
−1K152686Conquest FNSmith & Nephew2016—
0 (this device)K193029Conquest FNSmith & Nephew, Inc.2020—
+1K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.20211
+1K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100…Smith & Nephew, Inc.20221
+2K233017TM Plating SystemTyber Medical, LLC2023—
+1K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma2021—
+3K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198910
199010
199110
199320
199420
199520
199660
199830
199950
200070
200170
200240
200320
200440
200550
200640
200720
200820
201020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202120
202210
202330
202520
202620
FIG. 1 — Lineage of K193029, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K213126 Smith & Nephew, Inc. Plates and Screws…score 12.0 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K152686Conquest FN
Summary page 4
…performance characteristics. The subject bone plates feature characteristics very similar to the CONQUEST FN system bone plates cleared via K152686, with the primary differences being the elimination of the plate shaft and distal screw holes. All other design aspects…
Smith & Nephew2016—
*K111994Smith & Nephew Cannulated Screws and Washers
Summary page 5
…K152686 3/17/2016 Smith & Nephew Cannulated Screws and Smith & Nephew K111994 10/11/2011 Washers…
Smith & Nephew, Inc.2011—

Also cleared against K152686: 3 other devices →

What descends from it? (10)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.20217
K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.20222
K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211

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 24 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
  • 15 of the 74 ancestors have a recall of any class.
  • Of its descendants, K210837 (Smith & Nephew, Inc., 2021) has gone furthest, with 7 descendants of its own.
  • 3 other devices also cite its predicate K152686.

How does its category compare?

All JDO devices

JDO Device, Fixation, Proximal Femoral, Implant: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.

FDA decisions per year · JDO

1in 2023

2008: 22014: 12016: 12017: 12018: 12020: 12021: 12022: 12023: 12026 (partial year): 1
2007high 2 (2008) · low 0 (2007)2026

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

2013: 1
2007high 1 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JDO

1in 2025

2007: 42008: 12009: 12010: 62011: 62012: 92013: 522014: 152015: 192016: 442017: 262018: 182019: 102020: 192021: 102022: 32023: 52024: 22025: 1
2007high 52 (2013) · low 1 (2008)2025

MAUDE reports naming product code JDO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—04
20082—01
20090—01
20100—06
20110—06
20120—09
20130—152
20141—015
20150—019
20161—044
20171—026
20181—018
20190—010
20201—019
20211—010
20221—03
20231—05
20240—02
20250—01
20261—0—

What is it indicated for?

The Smith & Nephew CONQUEST FN is indicated for displaced and undisplaced intracapsular femoral neck fractures.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K193029: Conquest FN.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193029

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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