FAST-FIX FLEX^◊

FAST-FIX FLEX enables all-zone all-inside meniscal repair to treat tears previously not accessible*^2-4

+Enhanced Accessibility

FAST-FIX FLEX provides access to the posterior zone as well as the mid-body and anterior third of the meniscus, which has been shown to account for more than 40% of meniscal tears in stable adult knees^2,3,5

+Preserve Anatomy

~25% smaller needle insertion area and a ~20% stronger repair*^{^8,12}

+Increase Reliability*^2-4

One-handed 360° active deployment confirmed through touch, sound and sight²

NOTE: Bend tool does not provide measurement. Maximum bend degree was established by benchtop testing.
*Compared to predicate device as demonstrated in biomechanical testing

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References
1. BioMedGPS 2020.SmartTRAK Meniscus Repair-US Market Report.
2. Smith+Nephew 2021.Validation, FAST-FIX FLEX. Internal Report. 15010267 Rev A.
3. Smith+Nephew 2021.Validation, FAST-FIX FLEX. Attachment B. Internal Report. 15010267 Rev A.
4. Smith+Nephew 2021.FAST-FIX FLEX-Surgeon Surveys. Internal Memo.
5. Metcalf MH, Barrett GR. Prospective evaluation of 1485 meniscal tear patterns in patients with stable knees. Am J Sports Med. 2004;32(3):675-680.
6. Li WP, Chen Z, Song B, Yang R, Tan W. The FasT-Fix Repair Technique for Ramp Lesion of the Medial Meniscus. Knee Surg Relat Res. 2015;27(1):56-60.
7. Smith+Nephew 2020.Verification, Maximum Bend Deployment Force Reliability Test. Internal Report. 15010435 Rev A.
8. Smith+Nephew 2021.Competitive, FAST-FIX FLEX Dimensional Analysis. Internal Report. 15010919 Rev A.
9. Smith+Nephew 2020.Biomechanical Testing, FAST-FIX FLEX. Internal Report. 15010180 Rev A.
10. Smith+Nephew 2021.Competitive, FAST-FIX FLEX Dimensional Analysis. Internal Report. 15010919 Rev A.
11. Smith+Nephew 2021.Verification, Bend tool Multi-use. Internal Report. 15010955 Rev A.
12. Smith+Nephew 2021.Biomechanical Testing, FAST-FIX FLEX Competitive Devices. Internal Report. 15010920 Rev A.
13. Smith+Nephew 2019. Evidence Outcomes Reports EO/SPM/FASTFIX/002/v2 and EO/SPM/FASTFIX/003/v2.

Reference #   Description
72205324      FAST-FIX FLEX Curved with Bend Tool and Slotted Cannula
72205325      FAST-FIX FLEX Reverse Curved with Bend Tool and Slotted                                      Cannula
CTX-C001     NOVOCUT^◊ Suture Manager