Cleared Traditional

K981269 - UNIVERSAL DRIVE SYSTEM

K981269 is an FDA 510(k) clearance for UNIVERSAL DRIVE SYSTEM, manufactured by Linvatec Corp.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K981269 · Linvatec Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
78d
Days
Class 2
Risk

K981269 is an FDA 510(k) clearance for the UNIVERSAL DRIVE SYSTEM. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on June 24, 1998 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Linvatec Corp. devices

FDA 510(k) Submission Details - K981269

510(k) Number K981269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1998
Decision Date June 24, 1998
Days to Decision 78 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
44d faster than avg
Panel avg: 122d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRX Device Classification - Class 2, Special Controls

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
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 - HRX Arthroscope

All 521
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K981269.
INTEGRATED DRIVE/PUMP SYSTEM
K981636 · Linvatec Corp. · Aug 1998
MYELOTEC VIDEO GUIDED CATHETER
K980734 · Myelotec, Inc. · Aug 1998
KYPHON INFLATABLE BONE TAMP
K981251 · Kyphon, Inc. · Jul 1998
DYONICS INTELIJET INFLOW/OUTFLOW CANNULA
K981156 · Smith & Nephew, Inc. · May 1998
YEUNG ENDOSCOPIC SPINE SYSTEM
K973405 · Richard Wolf Medical Instruments Corp. · Mar 1998
PERCSCOPE MODEL 2600
K974579 · Clarus Medical Systems, Inc. · Feb 1998