510(k) Report

510(k) · Cleared

Cleared

Synthes Limited Contact-Dynamic Hip Screw Implant

K923613510(k) TraditionalCleared Jun 22, 1993336-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

Synthes (Usa) · JDO Device, Fixation, Proximal Femoral, Implant

Cleared on Jun 22, 1993 after a 336-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.

Decided
Jun 22, 1993
Review
336 days
Class
Class II
Product code
JDO
Recalls
None
Predicates
0

11 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2016: 1 descendant cleared2019: 1 descendant cleared2021: 1 descendant cleared2017: 2 descendants cleared2015: 1 descendant cleared2020: 1 descendant cleared2024: 1 descendant cleared2023: 1 descendant cleared2026: 2 descendants cleared1990200020102020
  1. This deviceK923613 Synthes Limited Contact-Dynamic Hip Screw ImplantSynthes (Usa) · 1993
  2. Descendant · cites it directly · 3 of its ownK191793 Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating…Nebula Surgical Private Limited · 2019
  3. Descendant · cites it directly · 3 of its ownK163383 GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating…Greens Surgicals Pvt., Ltd. · 2017
  4. Descendant · 2 generations on · 2 of its ownK242939 ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024
  5. Descendant · cites it directly · 1 of its ownK210247 OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma · 2021
  6. Descendant · cites it directly · 1 of its ownK153374 CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating…Orthocare · 2016

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2015: 12016: 12017: 22019: 12020: 12021: 12023: 12024: 12026: 2
2015high 2 (2017) · low 0 (2018)2026

Most influential descendants

Showing 5 of 11 · See all
  • K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited · 2019 · cites it directly3descendants
  • K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd. · 2017 · cites it directly3descendants
  • K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024 · 2 generations on2descendants
  • K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma · 2021 · cites it directly1descendant
  • K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare · 2016 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K923613Synthes Limited Contact-Dynamic Hip Screw ImplantSynthes (Usa)1993—
+1K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System…Nebula Surgical Private Limited2019—
+1K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System…Greens Surgicals Pvt., Ltd.2017—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical2024—
+1K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma2021—
+1K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE…Orthocare2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201610
201720
201910
202010
202110
202310
202410
202620
FIG. 1 — Lineage of K923613, 1993–2026Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193
K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173
K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211
K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161
K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151

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?

  • Of its descendants, K191793 (Nebula Surgical Private Limited, 2019) has gone furthest, with 3 descendants of its own.

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.

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—

More from Synthes (Usa)

406 FDA decisions under this applicant name. See the company

  • K131984Synthes Synsonic Ulna NailSynthes (Usa) · 2014
  • K111667Synthes Suprapatellar Insertion InstrumentsSynthes (Usa) · 20111 recall
  • K111540Synthes 3.5MM LCP Clavicle Plate SystemSynthes (Usa) · 2011
  • K110789Synthes Sternal Zipfix SystemSynthes (Usa) · 20113 recalls
  • K103002Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa) · 20112 recalls

Recent decisions in JDO

The JDO category page

  • K262184Gannet®BAAT Medical Products B.V. · 2026
  • K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies · 2023
  • K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip…Smith & Nephew, Inc. · 20221 recall
  • K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma · 2021
  • K193029Conquest FNSmith & Nephew, Inc. · 2020

https://510kreport.com/device/K923613 · printed Nov 6, 2026

Cite this page

510(k) Report. “K923613: Synthes Limited Contact-Dynamic Hip Screw Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K923613

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026