Cleared Traditional

K981636 - INTEGRATED DRIVE/PUMP SYSTEM

K981636 is the FDA 510(k) clearance for INTEGRATED DRIVE/PUMP SYSTEM by Linvatec Corp.. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K981636 · Linvatec Corp. · Orthopedic device
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Aug 1998
Decision
104d
Days
Class 2
Risk

K981636 is an FDA 510(k) clearance for the INTEGRATED DRIVE/PUMP SYSTEM. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on August 20, 1998 after a review of 104 days - within the typical 510(k) review window.

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: 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 Linvatec Corp. devices

Submission Details

510(k) Number K981636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1998
Decision Date August 20, 1998
Days to Decision 104 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
18d faster than avg
Panel avg: 122d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 361
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K981636.
DCI ENDOSCOPE
K983384 · KARL STORZ Endoscopy-America, Inc. · Nov 1998
XOMED FEATHERTOUCH XPS POWER RASP ATTACHMENT
K983025 · Xomed, Inc. · Nov 1998
STRYKER HIP ARTHOROSCOPY SET
K982375 · Stryker Endoscopy · Oct 1998
UNIVERSAL DRIVE SYSTEM
K981269 · Linvatec Corp. · Jun 1998
DYONICS INTELIJET INFLOW/OUTFLOW CANNULA
K981156 · Smith & Nephew, Inc. · May 1998
YEUNG ENDOSCOPIC SPINE SYSTEM
K973405 · Richard Wolf Medical Instruments Corp. · Mar 1998