Cleared Special

Tricera Arthroscopic System (K233493) - FDA 510(k) Clearance

Also marketed or referenced as:
Tricera Controller (R-10001) Tricera Shaver Handpiece (R-10023) Veriflow (R-10003) Exoflow (R-10017) 3-in-1 Shaver 4.2mm (R-10008) 3-in-1 Shaver 5.0mm (R-10014) Dynablator (R-10005) Standard Burr (R-10021) Standard Shaver 3.4mm (R-10012) Curved Standard Shaver 3.4mm (R-10024)

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K233493 · Relign Corporation · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2023
Decision
29d
Days
Class 2
Risk

K233493 is an FDA 510(k) clearance for the Tricera Arthroscopic System. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Relign Corporation (Campbell, US). The FDA issued a Cleared decision on November 28, 2023 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.4400 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Relign Corporation devices

Submission Details

510(k) Number K233493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2023
Decision Date November 28, 2023
Days to Decision 29 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 694
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