Cleared Traditional

K212870 - TLC Unicompartmental Knee System

K212870 is an FDA 510(k) clearance for TLC Unicompartmental Knee System, manufactured by Signature Orthopaedics Pty, Ltd.. The device is a Class 2 Orthopedic device with product code HSX cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K212870 · Signature Orthopaedics Pty, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2022
Decision
280d
Days
Class 2
Risk

K212870 is an FDA 510(k) clearance for the TLC Unicompartmental Knee System. Classified as Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (product code HSX), Class II - Special Controls.

Submitted by Signature Orthopaedics Pty, Ltd. (Lane Cove West, AU). The FDA issued a Cleared decision on June 16, 2022 after a review of 280 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3520 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Signature Orthopaedics Pty, Ltd. devices

FDA 510(k) Submission Details - K212870

510(k) Number K212870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2021
Decision Date June 16, 2022
Days to Decision 280 days
Submission Type Traditional
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
158d slower than avg
Panel avg: 122d · This submission: 280d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSX Device Classification - Class 2, Special Controls

Product Code HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3520
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 - HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer

All 109
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K212870.
OvertureTi Knee Resurfacing SystemTM
K242746 · Overture Orthopaedics · Oct 2024
TRIBRID® Unicompartmental Knee System
K232114 · Kyocera Medical Technologies, Inc. · Apr 2024
Uni Knee Resurfacing System
K221292 · Overture Resurfacing, Inc. · Mar 2023
Restoris Multi-Compartmental Knee System
K220930 · Mako Surgical Corp. · Jun 2022
Balanced Knee System Uni
K211471 · Ortho Development Corporation · Dec 2021
MOTOTM Partial Knee & MOTO PFJ Systems Extension
K213071 · Medacta International S.A. · Nov 2021