510(k) · Cleared
ClearedS4 Screw System™
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Subchondral Solutions · HWC Screw, Fixation, Bone
Cleared on Sep 7, 2017 as substantially equivalent to K123890 (Acumed, LLC, 2013) and 1 other predicate after a 400-day review. Its family tree reaches back 8 generations to 1996. 3 later devices descend from it.
- Decided
- Sep 7, 2017
- Review
- 400 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K962823 (1996). 79 ancestors in all, the oldest K792022 (1979). 3 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 7 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 6 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 5 generations backK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- 4 generations backK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
- 3 generations backK063298 Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
- 2 generations backK120493 Mini Cannulated Headed and Headless Screw SetInstratek, Inc. · 2012 · Recalled
- 1 generation backK123890 Acumed Cannulated Screw SystemAcumed, LLC · 2013 · Recalled
- This deviceK162171 S4 Screw System™Subchondral Solutions · 2017
- Descendant · cites it directly · 2 of its ownK191995 S4 Screw SystemSubchondral Solutions, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK231649 Intraosseous Fusion Device SystemAuxano Medical, LLC · 2023
- Descendant · cites it directly · 0 of its ownK220901 S-Core Implant SystemSubchondral Solutions, Inc. · 2022
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −7 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −6 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −5 | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| −4 | K060071 | Nexa Compression Screw | Nexa Orthopedics, Inc. | 2006 | — |
| −3 | K063298 | Osteomed Headless Cannulated Screw System | Osteomed LP | 2007 | — |
| −2 | K120493 | Mini Cannulated Headed and Headless Screw Set | Instratek, Inc. | 2012 | 1 |
| −1 | K123890 | Acumed Cannulated Screw System | Acumed, LLC | 2013 | 2 |
| 0 (this device) | K162171 | S4 Screw System™ | Subchondral Solutions | 2017 | — |
| +1 | K191995 | S4 Screw System | Subchondral Solutions, Inc. | 2020 | — |
| +2 | K231649 | Intraosseous Fusion Device System | Auxano Medical, LLC | 2023 | — |
| +1 | K220901 | S-Core Implant System | Subchondral Solutions, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1981 | 1 | 0 |
| 1989 | 3 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 6 | 0 |
| 1996 | 11 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 6 | 0 |
| 2002 | 7 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K123890 | Acumed Cannulated Screw SystemSummary page 4…omponents are manufactured from titanium alloy (Ti-6Al-4V per ASTM F136). Primary Predicate: Acumed Cannulated Screw System (Acumed LLC. – K123890) Additional Predicate: Arthrex Compression FT Screws (Arthrex, Inc. – K132217) Performance Data: Mechanical testing of… | 2013 |
| * | K132217 | Arthrex Compression FT ScrewsSummary page 4…V per ASTM F136). Primary Predicate: Acumed Cannulated Screw System (Acumed LLC. – K123890) Additional Predicate: Arthrex Compression FT Screws (Arthrex, Inc. – K132217) Performance Data: Mechanical testing of the worst case S4 Screw System™ and a predicate componen… | 2013 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 21 years and passes through 8 companies; a new generation was cleared every 3.0 years on median.
- 12 of the 79 ancestors have a recall of any class.
- Of its descendants, K191995 (Subchondral Solutions, Inc., 2020) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K123890.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The S4 Screw System™ is indicated for fixation of small bone fragments, such as apical fragments, osteochondral fragments and cancellous fragments, appropriate for the size of the device which may include the following: simple metaphyseal fractures; condylar fractures; osteochondritis dissecans; areas where accurate screw placement is vital; apical fragments (patellar rim, navicular); cancellous fragments (talus); osteochondral fragments (talar vault, femoral condyle); intra-articular fractures and osteochondral fixation and fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162171 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162171: S4 Screw System™.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162171
Report an extraction error
Are you the manufacturer?
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