510(k) Report

510(k) · Cleared

Cleared

Impress SFS System

K173910510(k) TraditionalCleared Sep 14, 2018266-day reviewClass II21 CFR 888.3010

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

Cable Fix Medical, LLC · JDQ Cerclage, Fixation

Cleared on Sep 14, 2018 as substantially equivalent to K031162 (Smith & Nephew, Inc., 2003) and 3 other predicates after a 266-day review. Its family tree reaches back 6 generations to 1979.

Decided
Sep 14, 2018
Review
266 days
Class
Class II
Product code
JDQ
Recalls
None
Predicates
4

Its longest line of descent runs back 6 generations to K792022 (1979). 57 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 2 other ancestors1996: 10 other ancestors2004: 1 other ancestor2001: 3 other ancestors1999: 3 other ancestors1998: 4 other ancestors1997: 8 other ancestors1993: 2 other ancestors1988: 1 other ancestor1984: 1 other ancestor1995: 5 other ancestors1994: 5 other ancestors1992: 2 other ancestors1990: 3 other ancestors1985: 1 other ancestorK792022 · Herbert Bone Screw · Zimmer, Inc. · 1979 · recalledK974876 · Bionx Distal Radius Screw · Bionx Implants, Inc. · 1998K992947 · Cannulated Smartscrew Models 224540C, 224570C · Bionx Implants, Ltd. · 1999K012001 · Smartscrew · Bionx Implants, Ltd. · 2001K030900 · Inion Otps Biodegradable Fixaton System · Inion, Ltd. · 2003K043248 · Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model AR-8921DS · Arthrex, Inc. · 200519801990200020102020
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 10 other ancestors3 generations back: 18 other ancestors4 generations back: 11 other ancestors5 generations back: 6 other ancestors6 generations back: 3 other ancestors K043248 · Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model AR-8921DS · Arthrex, Inc. · 2005K030900 · Inion Otps Biodegradable Fixaton System · Inion, Ltd. · 2003K012001 · Smartscrew · Bionx Implants, Ltd. · 2001K992947 · Cannulated Smartscrew Models 224540C, 224570C · Bionx Implants, Ltd. · 1999K974876 · Bionx Distal Radius Screw · Bionx Implants, Inc. · 1998K792022 · Herbert Bone Screw · Zimmer, Inc. · 1979 · recalled−50
  1. Root · 6 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
  2. 5 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
  3. 4 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
  4. 3 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
  5. 2 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
  6. 1 generation backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
  7. This deviceK173910 Impress SFS SystemCable Fix Medical, LLC · 2018
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K792022Herbert Bone ScrewZimmer, Inc.19796
−5K974876Bionx Distal Radius ScrewBionx Implants, Inc.1998—
−4K992947Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd.1999—
−3K012001SmartscrewBionx Implants, Ltd.2001—
−2K030900Inion Otps Biodegradable Fixaton SystemInion, Ltd.2003—
−1K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.…Arthrex, Inc.2005—
0 (this device)K173910Impress SFS SystemCable Fix Medical, LLC2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198510
198810
199030
199220
199320
199450
199550
1996100
199780
199840
199930
200130
200320
200410
FIG. 1 — Lineage of K173910, 1979–2018Source: 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 JDQ? 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 JDQ device

  1. #1 K261271 Cable-Ready® Cable Grip Systemscore 14.7 · 11 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? (4)

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
*K031162Smith & Nephew Orthopaedic Cabling System
Summary page 4
…Classification: 888.3010 Bone fixation cerclage Product Code: JDQ/Orthopedics, Class II Predicate Devices: Orthopedic Cable System, Smith & Nephew (K031162) Kirschner Wires (K-Wires), Steinmann Pins and Orthopedic Cable System, Synthes (K9…
Smith & Nephew, Inc.2003—
*K960385Sterile Kirschner Wires and Steinmann Pins
Summary page 4
…edic Cable System, Smith & Nephew (K031162) Kirschner Wires (K-Wires), Steinmann Pins and Orthopedic Cable System, Synthes (K960385, K953777) TightRope Syndesmosis Device, Arthrex (K043248) Description of Device: The Impress SFS System…
Depuy, Inc.1996—
*K953777Synthes Wire Mount
Summary page 4
…e System, Smith & Nephew (K031162) Kirschner Wires (K-Wires), Steinmann Pins and Orthopedic Cable System, Synthes (K960385, K953777) TightRope Syndesmosis Device, Arthrex (K043248) Description of Device: The Impress SFS System is cable…
Synthes (Usa)1996—
*K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…
Summary page 4
…es (K-Wires), Steinmann Pins and Orthopedic Cable System, Synthes (K960385, K953777) TightRope Syndesmosis Device, Arthrex (K043248) Description of Device: The Impress SFS System is cable system which includes components such as cables and which are manufactu…
Arthrex, Inc.2005—

Also cleared against K031162: 6 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 39 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
  • 4 of the 57 ancestors have a recall of any class.
  • 6 other devices also cite its predicate K031162.

How does its category compare?

All JDQ devices

JDQ Cerclage, Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · JDQ

2in 2025

2007: 12008: 22009: 22011: 62012: 32013: 12014: 22015: 52016: 42017: 12018: 62020: 42022: 22023: 32024: 32025: 22026 (partial year): 1
2007high 6 (2011) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDQ

130in 2024

2011: 130 days median2012: 134 days median2015: 92 days median2016: 129 days median2018: 101 days median2020: 93 days median2023: 141 days median2024: 130 days median
2007high 141 (2023) · low 92 (2015)2026

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

Recalls per year · JDQ

5in 2019

2008: 22010: 22013: 12015: 12019: 5
2007high 5 (2019) · low 0 (2007)2026

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

Adverse event reports per year · JDQ

84in 2025

2007: 52008: 252009: 192010: 282011: 302012: 1302013: 3212014: 2232015: 2052016: 2242017: 1382018: 1822019: 1582020: 1252021: 1412022: 1342023: 982024: 1152025: 84
2007high 321 (2013) · low 5 (2007)2025

MAUDE reports naming product code JDQ, 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
20071—05
20082—225
20092—019
20100—228
20116130030
201231340130
20131—1321
20142—0223
20155921205
201641290224
20171—0138
201861010182
20190—5158
20204930125
20210—0141
20222—0134
20233141098
202431300115
20252—084
20261—0—

What is it indicated for?

The Impress SFS System is indicated for general orthopaedic repair procedures. The Impress SFS System is also intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures.

Indications for use as stated in the FDA summary.

Also cleared against K031162

6 other devices cite the same predicate.

  • K233949ACCORD Cable SystemSmith & Nephew, Inc. · 2024
  • K223762Smith & Nephew ACCORD™ Cable SystemSmith & Nephew · 2023
  • K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc. · 2021
  • K201497EVOS Cabling SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2020
  • K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc. · 20132 recalls
  • K043252Cabling System Trochanter HookSmith & Nephew, Inc. · 2005

Recent decisions in JDQ

The JDQ category page

  • K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc. · 2026
  • K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda. · 2025
  • K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage SuturesArthrex, Inc. · 2025
  • K232733Mbrace CableMedacta International S.A. · 2024
  • K233949ACCORD Cable SystemSmith & Nephew, Inc. · 2024

https://510kreport.com/device/K173910 · printed Nov 6, 2026

Cite this page

510(k) Report. “K173910: Impress SFS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173910

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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