510(k) Report

FDA applicant

Solana Surgical, LLC

Memphis, TN8 decisions2009–201321 recalls

FDA records 8 decisions for Solana Surgical, LLC (Memphis, TN) from 2009 to 2013: 8 510(k) clearances. Most are in product codes KWD (Prosthesis, Toe, Hemi-, Phalangeal) and HWC (Screw, Fixation, Bone). Its devices cite 16 predicates, 0 of them its own earlier devices. 21 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Solana Surgical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

3in 2013

2009: 12012: 42013: 3
2009high 4 (2012) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

21in 2015

2015: 21
2009high 21 (2015) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Solana Surgical, LLC by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Solana Surgical, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • KWDProsthesis, Toe, Hemi-, Phalangeal4decisions
  • HWCScrew, Fixation, Bone2decisions
  • HRSPlate, Fixation, Bone1decision
  • JDRStaple, Fixation, Bone1decision

Whose devices does it build on?

Its devices cite 16 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K124045Fuseforce Implant SystemSolana Surgical, LLC · 20136cite it
  • K090127Metatarsal Decompression Implant, Model 100Solana Surgical, LLC · 20092cite it
  • K113752Metatarsal Decompression Implant Surgical Instrument SetSolana Surgical, LLC · 20121cites it
  • K132594Crosscheck Plating SystemSolana Surgical, LLC · 20131cites it
  • K122738Gaitway Implant System, Surgical Instrument SetSolana Surgical, LLC · 20121cites it

What has FDA decided for it lately?

  • K132594Crosscheck Plating SystemSolana Surgical, LLC · 201321 recalls
  • K131187Lesser Metatarsal Head Implant SystemSolana Surgical, LLC · 2013
  • K124045Fuseforce Implant SystemSolana Surgical, LLC · 2013
  • K122738Gaitway Implant System, Surgical Instrument SetSolana Surgical, LLC · 2012
  • K120390Solafix Twist Screw Implant System, Surgical Instrument SetSolana Surgical, LLC · 2012
  • K113752Metatarsal Decompression Implant Surgical Instrument SetSolana Surgical, LLC · 2012
  • K120029Hemi Phalangeal Implant Surgical Instrument SetSolana Surgical, LLC · 2012
  • K090127Metatarsal Decompression Implant, Model 100Solana Surgical, LLC · 2009

All 8 as Solana Surgical, LLC →

What has been recalled?

21 recalls linked to its devices; the latest:

  • K132594CrossCHECK Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-L3008; 3.0 x 10 mm…Jul 21, 2015Class II
  • K132594CrossCHECK Non-Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-N3008; 3.0 x 10…Jul 21, 2015Class II
  • K132594CROSSCHECK (R) Plating system, Utility Plate, 2-Hole, REF CCP-UTN2. Orthopedic use.Mar 6, 2015Class II
  • K132594CROSSCHECK (R) Plating system, LAPIDUS CX Plate, 2mm Step, Left, REF CCP-LPX2L.…Mar 6, 2015Class II
  • K132594CROSSCHECK (R) Plating system, LAPIDUS CX Plate, NEUTRAL, Left, REF CCP-LPX0L.…Mar 6, 2015Class II
  • K132594CROSSCHECK (R) Plating system, Y-PLATE CX, REF CCP-YPX1. Orthopedic use.Mar 6, 2015Class II

Other applicant names beginning “Solana”

FDA records each applicant name separately; these may or may not be the same firm.

Solana, Inc. 1