Who is the manufacturer of S-ROM FEMORAL HIP STEM(SIZES 12 X 06 X 115 AND 12 X 07 X 115)?

Johnson & Johnson Professionals, Inc. filed the 510(k) submission for S-ROM FEMORAL HIP STEM(SIZES 12 X 06 X 115 AND 12 X 07 X 115) (K961939).

What is the FDA product code for S-ROM FEMORAL HIP STEM(SIZES 12 X 06 X 115 AND 12 X 07 X 115)?

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

What is the regulatory pathway for S-ROM FEMORAL HIP STEM(SIZES 12 X 06 X 115 AND 12 X 07 X 115)?

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

What are the predicate devices for S-ROM FEMORAL HIP STEM(SIZES 12 X 06 X 115 AND 12 X 07 X 115)?

S-ROM Femoral Hip Stems (K851422); S-ROM Femoral Hip Stems (K913231); S-ROM Femoral Hip Stems (K921111); S-ROM Femoral Hip Stems (K934412); S-ROM Femoral Hip Stems (K910664); S-ROM Femoral Hip Stems (K954935); P.F.C. Total Hip System (K944518).

Who can help prepare an FDA 510(k) submission like S-ROM FEMORAL HIP STEM(SIZES 12 X 06 X 115 AND 12 X 07 X 115)?

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.

S-ROM FEMORAL HIP STEM(SIZES 12 X 06 X 115 AND 12 X 07 X 115)

K961939 · Johnson & Johnson Professionals, Inc. · LPH · Aug 13, 1996 · Orthopedic

Device Facts

Record ID	K961939
Device Name	S-ROM FEMORAL HIP STEM(SIZES 12 X 06 X 115 AND 12 X 07 X 115)
Applicant	Johnson & Johnson Professionals, Inc.
Product Code	LPH · Orthopedic
Decision Date	Aug 13, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3358
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The S-ROM Femoral Hip Stem - Sizes 12 x 06 x 115 and 12 x 07 x 115 is intended for non-cemented fixation as the femoral component of a total hip replacement system. The stems are indicated for use in primary and revision replacement surgery. The prosthesis may be used for the following conditions, as appropriate: - Osteoarthritis; - Traumatic Fractures; - Rheumatoid Arthritis; - Avascular Necrosis; and - Congenital Dislocation.

Device Story

S-ROM Femoral Hip Stem serves as femoral component in total hip replacement; intended for non-cemented fixation. Anatomically shaped with flutes and distal coronal slot; manufactured from Ti-6Al-4V. Used by orthopedic surgeons in clinical settings for primary or revision hip arthroplasty. Device provides structural support for hip joint; restores mobility; alleviates pain associated with degenerative or traumatic hip conditions. Implanted via surgical procedure.

Clinical Evidence

Bench testing only. Testing conducted in accordance with FDA Draft Guidance Document for Femoral Stem Prostheses and ISO 7206-4.

Technological Characteristics

Material: Ti-6Al-4V. Design: Anatomically shaped, fluted, distal coronal slot. Fixation: Uncemented, porous-coated. Standards: ISO 7206-4. Sterilization: Standard methods utilized for existing S-ROM product line.

Indications for Use

Indicated for primary and revision total hip replacement in patients with osteoarthritis, traumatic fractures, rheumatoid arthritis, avascular necrosis, or congenital dislocation requiring non-cemented femoral fixation.

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

S-ROM Femoral Hip Stems (K851422)
S-ROM Femoral Hip Stems (K913231)
S-ROM Femoral Hip Stems (K921111)
S-ROM Femoral Hip Stems (K934412)
S-ROM Femoral Hip Stems (K910664)
S-ROM Femoral Hip Stems (K954935)
P.F.C. Total Hip System (K944518)

Related Devices

K974331 — UNI-ROM TOTAL HIP SYSTEM FEMORAL STEM · Johnson & Johnson Professionals, Inc. · Feb 6, 1998
K053588 — PROFEMUR LX HIP STEM · Wrightmedicaltechnologyinc · Jan 13, 2006
K964218 — PERFECTA PLASMA SPRAY HIP STEM · Wrightmedicaltechnologyinc · Jan 8, 1997
K041109 — ZIMMER ANATOMIC II HIP PROSTHESIS · Zimmer, Inc. · Jul 20, 2004
K080625 — SMITH & NEPHEW MIS HIP STEM WITH STIKTITE · Smith & Nephew, Inc. · May 8, 2008

Submission Summary (Full Text)

{0} K961939 AUG 13 1996 # Appendix I 510(k) Summary of Safety and Effectiveness S-ROM® Total Hip System S-ROM® Femoral Hip Stem - Sizes 12 x 06 x 115 and 12 x 07 x115 Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, MA 02767 USA ## Contact Person J. Teresa Dorriety, Esq. Sr. Regulatory Affairs Specialist Phone: (508) 880-8404 Fax: (508) 828-3212 ## Name of Device Proprietary Name: S-ROM® Femoral Hip Stem - Sizes 12 x 06 x 115 and 12 x 07 x 115 Common Name: Femoral Hip Stem Classification Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis ## Device Classification This device has been placed in Class II for Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis per 21 CFR §888.3358. ## Statement of Substantial Equivalence The S-ROM Femoral Hip Stems (Sizes 12 x 06 x 115 and 12 x 07 x 115) are substantially equivalent to several hip prostheses currently marketed in the United States for hip replacement including the S-ROM Femoral Hip Stems cleared under #K851422, #K913231, #K921111, #K934412, #K910664 and #K954935. The subject device is also substantially equivalent to hip prostheses such as the P.F.C.® Total Hip System (#K944518). 000018 {1} The subject device is composed of the same materials as similar stems marketed in the United States. Further, the intended use, design, and manufacture of the S-ROM femoral hip stems 12 x 06 x 115 and 12 x 07 x 115 are substantially equivalent to currently distributed hip stems. Additionally, the packaging and method of sterilization are currently utilized for other S-ROM stems, as well as other stems currently distributed in the United States. ## Indications for Use The S-ROM Femoral Hip Stem - Sizes 12 x 06 x 115 and 12 x 07 x 115 is intended for non-cemented fixation as the femoral component of a total hip replacement system. The stems are indicated for use in primary and revision replacement surgery. The prosthesis may be used for the following conditions, as appropriate: - Osteoarthritis; - Traumatic Fractures; - Rheumatoid Arthritis; - Avascular Necrosis; and - Congenital Dislocation. ## Physical Description The S-ROM Femoral Hip Stems (Sizes 12 x 06 x 115 and 12 x 07 x 115) are manufactured from Ti-6Al-4V, the same material used to manufacture the S-ROM femoral hip stems in the larger sizes and that has been used in orthopaedic implants for many years with established clinical success. The S-ROM Femoral Hip Stems are anatomically shaped with flutes and a coronal slot in the distal portion of the stem. The size 12 x 06 x 115 and 12 x 07 x 115 stems, as well as the larger size S-ROM femoral hip stems, can be used in either the right or left hip. Testing was conducted per the FDA's Draft Guidance Document for Femoral Stem Prostheses, in accordance with ISO 7206-4. 000019