Cleared Traditional

K991398 - BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT

K991398 is an FDA 510(k) clearance for BONESOURCE HYDROXYAPATITE CEMENT (HAC) ..., manufactured by Stryker Leibinger. The device is a Class 2 General & Plastic Surgery device with product code GXP cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K991398 · Stryker Leibinger · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
153d
Days
Class 2
Risk

K991398 is an FDA 510(k) clearance for the BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT. Classified as Methyl Methacrylate For Cranioplasty (product code GXP), Class II - Special Controls.

Submitted by Stryker Leibinger (Kalamazoo, US). The FDA issued a Cleared decision on September 22, 1999 after a review of 153 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 882.5300 - the FDA general and plastic surgery device 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker Leibinger devices

FDA 510(k) Submission Details - K991398

510(k) Number K991398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1999
Decision Date September 22, 1999
Days to Decision 153 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 115d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXP Device Classification - Class 2, Special Controls

Product Code GXP Methyl Methacrylate For Cranioplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5300
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GXP Methyl Methacrylate For Cranioplasty

All 34
Devices cleared under the same product code (GXP) and FDA review panel - the closest regulatory comparables to K991398.
MODIFICATION TO: INJECTABLE MIMIX
K012569 · Biomet, Inc. · Dec 2001
PARALLAX CRANIOSET
K994022 · Parallax Medical, Inc. · Aug 2000
CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER
K990290 · Biomet, Inc. · Nov 1999
BSM- BONE SUBSTITUTE MATERIAL
K983009 · Etex Corp. · Nov 1998
MEDPOR SURGICAL GRANULE IMPLANTS
K982040 · Porex Surgical, Inc. · Sep 1998
NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE CEMENT- 5CC KIT, NORIAN CRANIAL REPAIR SYSTEM (CRS) BONE CEMENT- 10CC
K973789 · Norian Corp. · May 1998