Who is the manufacturer of NATURAL HIP SYSTEM POROUS STEM - COLLARLESS, COLLARED?

Intermedics Orthopedics filed the 510(k) submission for NATURAL HIP SYSTEM POROUS STEM - COLLARLESS, COLLARED (K963266).

What is the FDA product code for NATURAL HIP SYSTEM POROUS STEM - COLLARLESS, COLLARED?

LPH. It is classified under 21 CFR 888.3358 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for NATURAL HIP SYSTEM POROUS STEM - COLLARLESS, COLLARED?

510(k) clearance (submission type: Traditional).

What are the predicate devices for NATURAL HIP SYSTEM POROUS STEM - COLLARLESS, COLLARED?

Porous Natural Hip Stem (K913060); Stability Hip Stem (K915787, K934457).

Who can help prepare an FDA 510(k) submission like NATURAL HIP SYSTEM POROUS STEM - COLLARLESS, COLLARED?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

NATURAL HIP SYSTEM POROUS STEM - COLLARLESS, COLLARED

K963266 · Intermedics Orthopedics · LPH · Oct 15, 1996 · Orthopedic

Device Facts

Record ID	K963266
Device Name	NATURAL HIP SYSTEM POROUS STEM - COLLARLESS, COLLARED
Applicant	Intermedics Orthopedics
Product Code	LPH · Orthopedic
Decision Date	Oct 15, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3358
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Natural Hip System Porous Stem is intended for use in cases of total hip or hemi-hip arthroplasty.

Device Story

Femoral component of total hip prosthesis; uncemented, porous-coated design. Input: surgical site anatomy. Transformation: provides structural replacement for femoral head/neck; utilizes Sulzer 12/14 neck trunnion for attachment to ceramic femoral heads. Output: mechanical support for hip joint. Used in OR by orthopedic surgeons. Features: collared/collarless options; Cancellous Structured Titanium (CSTi) porous coating for fixation; anterior angulation; distal ribs/flutes; flared coronal slot. Benefits: restores joint function; enables biological fixation via porous coating.

Clinical Evidence

Bench testing only. Theoretical stress analysis performed; device demonstrated ability to endure 10 million cycles of fatigue testing without integrity compromise.

Technological Characteristics

Material: Titanium alloy with Cancellous Structured Titanium (CSTi) porous coating. Design: Uncemented, semi-constrained, porous-coated femoral stem. Features: Sulzer 12/14 neck trunnion, anterior angulation, distal ribs/flutes, flared coronal slot. Available in collared and collarless configurations.

Indications for Use

Indicated for patients requiring total hip or hemi-hip arthroplasty.

Regulatory Classification

Identification

A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Predicate Devices

Porous Natural Hip Stem (K913060)
Stability Hip Stem (K915787, K934457)

Related Devices

K974331 — UNI-ROM TOTAL HIP SYSTEM FEMORAL STEM · Johnson & Johnson Professionals, Inc. · Feb 6, 1998
K150302 — PROFEMUR Preserve Classic Stem · Microport Orthopedics, Inc. · Apr 10, 2015
K021403 — HA MALLORY/HEAD POROUS FEMORAL STEM & HA MALLORY/HEAD POROUS LATERALIZED FEMORAL STEM · Biomet Orthopedics, Inc. · May 31, 2002
K141001 — ALPINE HIP STEM; ALPINE HA HIP STEM · Ortho Development · Jul 30, 2014
K042337 — ZIMMER M/L TAPER HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING · Zimmer, Inc. · Nov 4, 2004

Submission Summary (Full Text)

{0} OCT 15 1996 Summary of Safety and Effectiveness for Natural Hip System Porous Stem K963266 August 19, 1996 In accordance with the Food and Drug Administration Interim Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21CFR 807, this is to serve as a 510(k) Summary for the Natural Hip System Porous Stem. Submitter: Intermedics Orthopedics, Inc. (IOI) 9900 Spectrum Drive Austin, Texas, 78717 Tel.: (512) 432-9900 Fax: (512) 432-9291 Contact Person: Regarding this submission: Name: Sam Mirza Tel.: 512-432-9751 Fax: 512-432-9291 Official Correspondent Name: Jacquelyn Hughes Tel.: 512-432-9687 Fax.: 512-432-9291 Proprietary name: Natural Hip System Porous Stem Common Name: Total Hip Prosthesis - Femoral Component Classification name: Hip joint metal/ceramic/polymer semi-constrained porous coated uncemented prosthesis, 21 CFR 888.3358 Predicate Devices: The features employed by Natural Hip Stem Porous Stem are substantially equivalent to the features employed by the following predicate legally marketed devices: Porous Natural Hip Stem: Intermedics Orthopedics, Inc. (510(k) K913060). Stability Hip Stem: Depuy Inc. (510(k)s K915787 and K934457). {1} # Device Description: The Natural Hip System Porous Stem is identical in design geometry as compared to the predicate IOI Porous Natural Hip Stem, except for the reduction in the neck length. This design change was intended to address various patient population in cases of total hip or hemi-hip arthroplasty. The Natural Hip System Porous Stem employs a Sulzer 12/14 configured neck trunnion for attachment to IOI's femoral heads, including Biolox and Zirconia ceramic heads, featuring a Sulzer 12/14 configured bore. The Natural Hip System Porous Stem is available in both collared and collarless design. The Natural Hip System with Collar employs Cancellous Structured Titanium (CSTi™) porous coating on the inferior surface of the collar. The proximal surface of the Natural Hip System Porous Stem employs anterior angulation to match the anatomic angulation of a natural femur. In addition, the proximal surface of the Natural Hip System Porous Stem employs circumferential CSTi™ porous coating. The distal portion of the Natural Hip System Porous Stem employs ribs and flutes on the anterior and posterior sides of the hip stem. In addition, the distal portion of the Natural Hip System Porous Stem employs a flared coronal slot. The results of the theoretical stress analysis demonstrate that the Natural Hip System Porous Stem can successfully endure a fatigue test regimen of 10 million cycles without compromising the integrity of the hip stem.