SL-PLUS LATERALIZED STEM

K021178 · Plus Orthopedics · JDI · May 14, 2002 · Orthopedic

Device Facts

• Record ID: K021178
• Device Name: SL-PLUS LATERALIZED STEM
• Applicant: Plus Orthopedics
• Product Code: JDI · Orthopedic
• Decision Date: May 14, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SL-PLUS® Lateralized Stem is intended for treating patients who are candidates for total hip arthroplasty because the natural femoral head and neck has been subject to disease or trauma. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.

Device Story

The SL-PLUS® Lateralized Stem is a cementless femoral component for total hip arthroplasty. It is a modification of the predicate SL-PLUS® Stem, providing increased offset (6 mm to 8.5 mm) and a 123° CCD angle to better accommodate patient anatomy. The device is implanted by an orthopedic surgeon in a clinical/OR setting. It functions as a mechanical prosthesis to replace the femoral head and neck, aiming to relieve hip pain and restore joint motion. No software or electronic components are involved.

Clinical Evidence

Bench testing only. Biomechanical fatigue testing was performed on the worst-case model, with results showing performance equal to or better than the predicate and other commercially available devices, sufficient for in vivo loading.

Technological Characteristics

Cementless femoral hip prosthesis. Material and surface characteristics are identical to the predicate SL-PLUS® Stem. Features 12 sizes with offsets ranging from 6 mm to 8.5 mm and a 123° CCD angle. Mechanical device; no energy source, software, or connectivity.

Indications for Use

Indicated for patients requiring total hip arthroplasty due to disease or trauma of the femoral head and neck. Contraindications: acute/chronic local or systemic infections; serious muscle, nerve, or blood vessel lesions; poor bone quality or bony defects; concurrent disease interfering with implant function.

Regulatory Classification

Identification

A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• SL-PLUS® and SLR-PLUS® Stems (K001942)

Submission Summary (Full Text)

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AY 1 4 ZUUZ

SPECIAL 510(K) DEVICE MODIFICATION SL-PLUS® Lateralized Stem April 15, 2002

Kou178

page 1 of 1

## 510(k) Summary of Safety and Effectiveness

[in accordance with SMDA of 1990, 21 CFR 807.92(c)]

Contact:

PLUS ORTHOPEDICS 6055 Lusk Blvd. San Diego, CA 92121 Tel: [phone] x 2506 Attn: Mr. Hartmut Loch, RAC Director, Regulatory Affairs

SL-PLUS® Lateralized Stem Trade name:

Total Hip Joint, Femoral Component, Cementless Common name:

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Classification 21 CFR 888.3350 (87 LWJ and 87 JDI) name:

SL-PLUS® and SLR-PLUS® Stems, K001942, S/E 7/25/00 Equivalence:

We added 12 sizes, sizes 1 through 12, of lateralized stems to the SL-Device Modification PLUS® Stems, which were cleared for marketing by FDA on 7/25/00 Description: (K001942). These stems allow for a larger offset from 6 mm (size 1) up to 8.5 mm (size 12) compared to the standard SL-PLUS® Stem, thus giving the surgeon a further option to meet the patient's anatomy. The CCD angle is 123° compared to 131° for the standard SL-PLUS® Stem. Material and surface characteristics remain unchanged.

Indications:

The SL-PLUS® Lateralized Stem is intended for treating patients who are candidates for total hip arthroplasty because the natural femoral head and neck has been subject to disease or trauma. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.

Contraindications include acute or chronic infections (local or systemic), Contraindications: serious lesions of muscles, nerves or blood vessels, which put the affected limb at risk, bony defects or poor bone quality, which might endanger the stability of the prosthesis, and any concurrent disease, which might interfere with the function of the implant.

Biomechanical fatigue tests have been performed on the worst-case model. Performance data: The test results were equal or better to the predicate and other commercially available devices, and they are sufficient for in vivo loading.

15

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 1 4 2002

Mr. Hartmut Loch, RAC Director, Regulatory Affairs Plus Orthopedics 6055 Lusk Blvd. San Diego, CA 92121-2700

Re: K021178

Trade/Device Name: SL-Plus® Lateralized Stem Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JDI, LWJ Dated: April 15, 2002 Received: April 15, 2002

Dear Mr. Loch:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Hartmut Loch, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

O Mark N Milbersen

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SPECIAL 510(K) DEVICE MODIFICATION SL-PLUS® Lateralized Stem April 15, 2002

Page 1

510(k) Number: O21178

Device Name(s):

SL-PLUS® Lateralized Stem

Indications for Use:

The SL-PLUS® Lateralized Stem is intended for treating patients who are candidates for total hip arthroplasty because the natural femoral head and neck has been subject to disease or trauma. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark N. Mulkern

Division of General. Restorative and Neurological Devices

510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

(Optional format 1-2-96)

Over-The-Counter-Use No