510(k) · Cleared
ClearedOptossol Compression Device System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genossis, LLC · JDW Pin, Fixation, Threaded
Cleared on May 30, 2014 as substantially equivalent to K130298 (Biopro, Inc., 2013) after a 56-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- May 30, 2014
- Review
- 56 days
- Class
- Class II
- Product code
- JDW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K962823 (1996). 16 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 5 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 4 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 3 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 2 generations backK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- 1 generation backK130298 Biopro Kwick-Wire Universal Screw SystemBiopro, Inc. · 2013
- This deviceK140875 Optossol Compression Device SystemGenossis, LLC · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −4 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −3 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −2 | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| −1 | K130298 | Biopro Kwick-Wire Universal Screw System | Biopro, Inc. | 2013 | — |
| 0 (this device) | K140875 | Optossol Compression Device System | Genossis, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 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 JDW? 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 JDW device
- #1 K260073 XT3 System; XT3 System, Mini; XT3 System…score 15.0 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K130298 | Biopro Kwick-Wire Universal Screw SystemSummary page 2…instruments in orthopedics. Copredia t OptOSSOlTM Compression Device System has the same intended use as the predicate Devices device contained in K130298. The technological characteristics of material composition and dimensional specifications fall within the ran… | 2013 |
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 18 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 16 ancestors has a recall of any class.
- 1 other device also cites its predicate K130298.
How does its category compare?
All JDW devicesJDW Pin, Fixation, Threaded: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · JDW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDW
Too few JDW 510(k)s in any year since 2007 to give a median.
Recalls per year · JDW
21in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDW
29in 2025
MAUDE reports naming product code JDW, 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 | 2 | — | 0 | 25 |
| 2008 | 0 | — | 0 | 26 |
| 2009 | 1 | — | 2 | 29 |
| 2010 | 2 | — | 2 | 29 |
| 2011 | 1 | — | 0 | 55 |
| 2012 | 1 | — | 52 | 75 |
| 2013 | 2 | — | 0 | 69 |
| 2014 | 2 | — | 0 | 27 |
| 2015 | 1 | — | 0 | 70 |
| 2016 | 0 | — | 0 | 46 |
| 2017 | 1 | — | 2 | 43 |
| 2018 | 1 | — | 21 | 94 |
| 2019 | 1 | — | 0 | 575 |
| 2020 | 2 | — | 0 | 402 |
| 2021 | 2 | — | 0 | 168 |
| 2022 | 2 | — | 0 | 121 |
| 2023 | 0 | — | 0 | 72 |
| 2024 | 0 | — | 0 | 65 |
| 2025 | 2 | — | 0 | 29 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Optassolm Compression Device System Is indicated for use in the Internal fixation of fractures,
fusions and revisions. The system Is intended for but not limited to hand surgery, orthopedic surgery
and podiatric surgery - but is not Intended for Spinal Use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140875 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140875: Optossol Compression Device System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140875
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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