Acute QC Strut and Components
FDA 510(k) K221792 · Smith & Nephew, Inc.
510(k) numberK221792
Submission
- Device name
- Acute QC Strut and Components
- Applicant
- Smith & Nephew, Inc.
Cordova, TN, US - Received
- June 21, 2022
- Decision date
- August 25, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OSN – Software For Diagnosis/Treatment
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Software associated with an orthopedic trauma device which is intended for the diagnosis or treatment of traumatic or reconstructive orthopedic conditions
Other 510(k)s with product code OSN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253764 | ENOS Software Guided External Fixation SystemOSN · Traditional | Disior, Ltd. | 02/26/2026SE |
| K180539 | Deformity Analysis and Correction Software (DACS) and InstrumentationOSN · Traditional | Arrowhead Medical Device Technologies, LLC | 08/13/2018SE |
| K140550 | Orthohub External Fixator SoftwareOSN · Traditional | Orthohub, Inc. | 08/25/2014SE |
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| 510(k) | Device | Decision |
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| K254084 | AETOS Shoulder System - CONCELOC GlenoidsKWS · Traditional | 04/06/2026SE |
| K252416 | AETOS Shoulder System Meta Humeral Prosthesis Size 0KWS · Traditional | 10/29/2025SE |
| K252129 | AETOS Shoulder System Stemless Humeral ProsthesisPKC · Traditional | 10/03/2025SE |
| K251627 | BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…MBI · Special | 06/25/2025SE |
| K243608 | TRIGEN Stable Lock Nut & WasherJDS · Traditional | 06/12/2025SE |
| K250677 | LEGION Total Knee SystemJWH · Special | 04/02/2025SE |
| K250571 | CATALYSTEM Femoral StemsLZO · Special | 03/28/2025SE |
| K241666 | EVOS Pelvic and Acetabular SystemHRS · Traditional | 02/19/2025SE |
Questions and answers
When was Acute QC Strut and Components cleared by the FDA?
Acute QC Strut and Components (K221792) received a 510(k) decision of Substantially Equivalent on August 25, 2022, 65 days after the submission was received.
What is the product code of K221792?
The FDA product code is OSN – Software For Diagnosis/Treatment, a Class II (moderate risk) device regulated under 21 CFR 888.3030.