FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)
K Number: K251627
·
Decision Jun 25, 2025
Classifications
1
FEI Numbers
263
Registration Numbers
263
Same Product Code
564
Applicant Total
83
Review Days
28
Basic Information
- Device Name
- BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)
- K Number
- K251627
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Smith & Nephew, Inc.
- Date Received
- May 28, 2025
- Decision Date
- June 25, 2025
- Product Code
- MBI
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MBI), ordered by most recent decision date.
Arthrex PushLock Suture Anchors
FDA 510(k)
FDA Class 2
·Orthopedic
SnugFit ASA Extension
FDA 510(k)
FDA Class 2
·Orthopedic
CONMED Argo Knotless® Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP T; RIGIDLOOP Clip; RIGIDLOOP BTB; RIGIDLOOP Suture Loop
FDA 510(k)
FDA Class 2
·Orthopedic
Shoulder Soft Tissue Anchors
FDA 510(k)
FDA Class 2
·Orthopedic
Arthrex FiberTak Suture Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Smith & Nephew, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K243608 | TRIGEN Stable Lock Nut & Washer | Jun 12, 2025 | Substantially Equivalent |
| K250677 | LEGION Total Knee System | Apr 2, 2025 | Substantially Equivalent |
| K243364 | TRIGEN META-TAN Trochanteric Antegrade Nail | Dec 9, 2024 | Substantially Equivalent |
| K240716 | AETOS Shoulder System Stemless Humeral Prosthesis | Nov 20, 2024 | Substantially Equivalent |
| K242711 | JOURNEY II Unicompartmental Knee System (JOURNEY II UK) | Oct 30, 2024 | Substantially Equivalent |
| K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems | Oct 21, 2024 | Substantially Equivalent |
| K242375 | OR3O Dual Mobility System | Oct 7, 2024 | Substantially Equivalent |
| K240061 | TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System | Sep 20, 2024 | Substantially Equivalent |
| K241435 | Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, co-braid-blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, co-braid-blue | Jun 20, 2024 | Substantially Equivalent |
| K233949 | ACCORD Cable System | Mar 13, 2024 | Substantially Equivalent |