510(k) Report

510(k) · Cleared

Cleared

Dynamic Condylar Screw or D.C.S.

K840954510(k) TraditionalCleared May 11, 198467-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) · HRS Plate, Fixation, Bone

Cleared on May 11, 1984 after a 67-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it.

Decided
May 11, 1984
Review
67 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
0

16 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2016: 1 descendant cleared2023: 2 descendants cleared2015: 2 descendants cleared2017: 2 descendants cleared2012: 1 descendant cleared2021: 2 descendants cleared2020: 2 descendants cleared2024: 1 descendant cleared2026: 2 descendants cleared19801990200020102020
  1. This deviceK840954 Dynamic Condylar Screw or D.C.S.Synthes (Usa) · 1984
  2. Descendant · cites it directly · 4 of its ownK071852 Aap Aps SystemAap Implantate AG · 2007
  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 · 2 of its ownK150818 Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation…Zimmer, Inc. · 2015 · Recalled
  6. Descendant · 2 generations on · 2 of its ownK120360 Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited · 2012

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2007: 12012: 12015: 22016: 12017: 22020: 22021: 22023: 22024: 12026: 2
2007high 2 (2015) · low 0 (2008)2026

Most influential descendants

Showing 5 of 16 · See all
  • K071852Aap Aps SystemAap Implantate AG · 2007 · cites it directly4descendants
  • 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
  • K150818Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral…Zimmer, Inc. · 2015 · cites it directly2descendants
  • K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited · 2012 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K840954Dynamic Condylar Screw or D.C.S.Synthes (Usa)1984—
+1K071852Aap Aps SystemAap Implantate AG2007—
+1K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System…Greens Surgicals Pvt., Ltd.2017—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical2024—
+1K150818Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System…Zimmer, Inc.20156
+2K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201210
201520
201610
201720
202020
202120
202320
202410
202620
FIG. 1 — Lineage of K840954, 1984–2026Source: 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 HRS? 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 HRS device

  1. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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? (16)

See all 16

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

NumberDeviceApplicantDecidedDescendants
K071852Aap Aps SystemAap Implantate AG20074
K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173
K150818Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral…Zimmer, Inc.20152
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
K221787Auxein's DHS/DCS Plate SystemAuxein Medical Private Limited20230

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, K071852 (Aap Implantate AG, 2007) has gone furthest, with 4 descendants of its own.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRS

54in 2025

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
2007high 25 (2019) · low 0 (2014)2026

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

Adverse event reports per year · HRS

2,306in 2025

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, 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
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

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 HRS

The HRS category page

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K263407Tempo Plating SystemPace Surgical · 2026
  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
  • K261611TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2026
  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K840954 · printed Nov 5, 2026

Cite this page

510(k) Report. “K840954: Dynamic Condylar Screw or D.C.S..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K840954

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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