Cleared Special

Tricera Arthroscopic System (K241008) - FDA 510(k) Clearance

Also marketed or referenced as:
Tricera Controller (R-10001) Tricera Handpiece, Autoclavable (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 5.0mm (R-10021) Standard Shaver 3.4mm (R-10012) Curved Standard Shaver 3.4mm (R-10024) Curved Standard Ball Burr XL, 5.0mm (R-10025) Curved Shaver XL 4.2mm (R-10026) Curved Dynablator, XL (R-10027)

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

K241008 · Relign Corporation, Subsidiary of Zimmer Biomet · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
26d
Days
Class 2
Risk

K241008 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, Subsidiary of Zimmer Biomet (Campbell, US). The FDA issued a Cleared decision on May 8, 2024 after a review of 26 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, Subsidiary of Zimmer Biomet devices

Submission Details

510(k) Number K241008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2024
Decision Date May 08, 2024
Days to Decision 26 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
96d faster than avg
Panel avg: 122d · This submission: 26d
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.

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