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, Inc. · HWC Screw, Fixation, Bone
Cleared on Apr 18, 2020 as substantially equivalent to K162171 (Subchondral Solutions, 2017) and 2 other predicates after a 267-day review. Its family tree reaches back 9 generations to 1996. 2 later devices descend from it.
- Decided
- Apr 18, 2020
- Review
- 267 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K962823 (1996). 90 ancestors in all, the oldest K792022 (1979). 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 5 generations between
- 3 generations backK120493 Mini Cannulated Headed and Headless Screw SetInstratek, Inc. · 2012 · Recalled
- 2 generations backK123890 Acumed Cannulated Screw SystemAcumed, LLC · 2013 · Recalled
- 1 generation backK162171 S4 Screw System™Subchondral Solutions · 2017
- This deviceK191995 S4 Screw SystemSubchondral Solutions, Inc. · 2020
- Descendant · cites it directly · 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
Show all 9 generations
- Root · 9 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 8 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 7 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 6 generations backK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- 5 generations backK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
- 4 generations backK063298 Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
- 3 generations backK120493 Mini Cannulated Headed and Headless Screw SetInstratek, Inc. · 2012 · Recalled
- 2 generations backK123890 Acumed Cannulated Screw SystemAcumed, LLC · 2013 · Recalled
- 1 generation backK162171 S4 Screw System™Subchondral Solutions · 2017
- This deviceK191995 S4 Screw SystemSubchondral Solutions, Inc. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −8 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −7 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −6 | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| −5 | K060071 | Nexa Compression Screw | Nexa Orthopedics, Inc. | 2006 | — |
| −4 | K063298 | Osteomed Headless Cannulated Screw System | Osteomed LP | 2007 | — |
| −3 | K120493 | Mini Cannulated Headed and Headless Screw Set | Instratek, Inc. | 2012 | 1 |
| −2 | K123890 | Acumed Cannulated Screw System | Acumed, LLC | 2013 | 2 |
| −1 | K162171 | S4 Screw System™ | Subchondral Solutions | 2017 | — |
| 0 (this device) | K191995 | S4 Screw System | Subchondral Solutions, Inc. | 2020 | — |
| +1 | 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 | 3 | 0 |
| 2001 | 6 | 0 |
| 2002 | 8 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 5 | 0 |
| 2013 | 2 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K162171 | S4 Screw System™Summary page 4…readed bone fixation fastener Device Class Class II Product Code: HWC Predicate Devices Primary Predicate: Subchondral Solutions, Inc. S4 Screw System (K162171) Additional Predicates: Acumed Cannulated Screw System (K123890) Medacta International M.U.S.T. Sacral Ili… | 2017 |
| * | K123890 | Acumed Cannulated Screw SystemSummary page 4…ct Code: HWC Predicate Devices Primary Predicate: Subchondral Solutions, Inc. S4 Screw System (K162171) Additional Predicates: Acumed Cannulated Screw System (K123890) Medacta International M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System (K17159… | 2013 |
| * | K171595 | M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemSummary page 4…cates: Acumed Cannulated Screw System (K123890) Medacta International M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System (K171595) Reference Devices: Newclip Technics (K160617) Tyber Medical, Trauma Screw (K153575) Device Description T… | 2017 |
| † | K160617 | Large Screws Range | 2016 |
| † | K153575 | Tyber Medical Trauma Screw | 2016 |
What descends from it? (2)
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 24 years and passes through 9 companies; a new generation was cleared every 2.6 years on median.
- 13 of the 90 ancestors have a recall of any class.
- Of its descendants, K231649 (Auxano Medical, LLC, 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K162171.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Minimally invasive reconstruction of fractures and joints; Adjuvant for osteosynthesis in complex joint fractures; Multifragment joint fractures; Simple metaphyseal fractures, Fractures of the wrist, ankle, elbow, and shoulder, Condylar fractures; Osteochrondritis dissecans, Ostero-Chondral Fractures, Ligament avulsion injuries, Ligament fixation, Other small fragment, cancellous bone fractures, Small joint fusion. Areas where accurate screw placement is…
Read the full statement (220 words)
Minimally invasive reconstruction of fractures and joints; Adjuvant for osteosynthesis in complex joint fractures;
Multifragment joint fractures; Simple metaphyseal fractures, Fractures of the wrist, ankle, elbow, and shoulder, Condylar
fractures; Osteochrondritis dissecans, Ostero-Chondral Fractures, Ligament avulsion injuries, Ligament fixation, Other
small fragment, cancellous bone fractures, Small joint fusion. Areas where accurate screw placement is vital. Metatarsal
and phalangeal osteotomies; Fractures of the tarsals, metatarsals and other fractures of the foot; Avulsion fractures and
fractures of metatarsal V; Tarso-metatarsal and metatarso-phalangeal arthrodesis; Tarsal Fusions; Calcaneal and talar
fractures, Subtalar arthrodesis, Ankle arthrodesis. Fractures of small joints, such as: Ankle fractures, Navicular fractures,
Fractures of the fibula, malleolus, and calcaneus, Distal tibia and pilon fractures, Acetabular fractures. Other fractures of
the pelvic ring; Fractures of the femoral head and neck, Supracondylar femoral fractures, Slipped capital femoral
epiphyses, An adjunct to DHIS in basilar neck fractures, Intercondylar femur fractures, Intracapsular fractures of the hip,
Fractures of the distal femur and proximal tibia, Patellar fractures, Tibial plateau fractures. Small fragments of the hand
and wrist, Fractures of the carpals and metacarpals, Carnal and metacarpal arthrodesis, Scaphoid fracture and other
fractures of the hand, Phalangeal and interphalangeal fractures, Fractures of the ulna and radius. Radial head fractures,
Fractures of the olecranon and distal humerus, Humeral head fractures, Ligament fixation at the proximal humerus,
Glenoid fractures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K191995 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191995: 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/K191995
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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