510(k) · Cleared
ClearedAcute QC Strut and Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · OSN Software For Diagnosis/Treatment
Cleared on Aug 25, 2022 as substantially equivalent to K210953 (Smith & Nephew, Inc., 2021) and 1 other predicate after a 65-day review. Its family tree reaches back 13 generations to 1996.
- Decided
- Aug 25, 2022
- Review
- 65 days
- Class
- Class II
- Product code
- OSN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K962616 (1996). 55 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 13 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 9 generations between
- 3 generations backK110069 Smith & Nephew, Inc Spatialframe V4.1 Web-Based SoftwareSmith & Nephew, Inc. · 2011
- 2 generations backK142520 Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based softwareSmith & Nephew, Inc. · 2014 · Recalled
- 1 generation backK210953 SMART Taylor Spatial FrameSmith & Nephew, Inc. · 2021
- This deviceK221792 Acute QC Strut and ComponentsSmith & Nephew, Inc. · 2022
Show all 13 generations
- Root · 13 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 12 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 11 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 10 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 9 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 8 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 7 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 6 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 5 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 4 generations backK093047 Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc. · 2010 · Recalled
- 3 generations backK110069 Smith & Nephew, Inc Spatialframe V4.1 Web-Based SoftwareSmith & Nephew, Inc. · 2011
- 2 generations backK142520 Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based softwareSmith & Nephew, Inc. · 2014 · Recalled
- 1 generation backK210953 SMART Taylor Spatial FrameSmith & Nephew, Inc. · 2021
- This deviceK221792 Acute QC Strut and ComponentsSmith & Nephew, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −12 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −11 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −10 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −9 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −8 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −7 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −6 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −5 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −4 | K093047 | Smith & Nephew Circular Fixation System | Smith & Nephew, Inc. | 2010 | 1 |
| −3 | K110069 | Smith & Nephew, Inc Spatialframe V4.1 Web-Based Software | Smith & Nephew, Inc. | 2011 | — |
| −2 | K142520 | Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software | Smith & Nephew, Inc. | 2014 | 1 |
| −1 | K210953 | SMART Taylor Spatial Frame | Smith & Nephew, Inc. | 2021 | — |
| 0 (this device) | K221792 | Acute QC Strut and Components | Smith & Nephew, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 7 | 0 |
| 2001 | 6 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2008 | 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 OSN? 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 OSN device
- #1 K253764 ENOS Software Guided External Fixation Systemscore 15.1 · 15 generations · no Class I recall
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 |
|---|---|---|---|
| * | K210953 | SMART Taylor Spatial FrameSummary page 4…Class II Panel Code: Orthopedics/87 Product Code: KTT, OSN, JDW Predicate Device: Primary Predicate – K210953 – SMART Taylor Spatial Frame (S.E. 07/29/2021) Secondary Predi… | 2021 |
| * | K994143 | Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular)…Summary page 4…Primary Predicate – K210953 – SMART Taylor Spatial Frame (S.E. 07/29/2021) Secondary Predicate – K994143 – ILIZAROV™ External Fixation System (S.E. 02/18/2000)… | 2000 |
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 26 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 16 of the 55 ancestors have a recall of any class.
- 1 other device also cites its predicate K210953.
How does its category compare?
All OSN devicesOSN Software For Diagnosis/Treatment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · OSN
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · OSN
Too few OSN 510(k)s in any year since 2007 to give a median.
Recalls per year · OSN
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OSN
9in 2023
MAUDE reports naming product code OSN, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 1 | 1 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 1 | — | 1 | 2 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
1. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
2. Open and closed fracture fixation
3. Pseudarthrosis of long bones
4. Limb lengthening by distraction
5. Correction of bony or soft tissue deformities
6. Joint arthrodesis
7. Infected fractures
8. Nonunions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221792 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221792: Acute QC Strut and Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221792
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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