SL-PLUS AND SLR-PLUS STEMS

K001942 · Plus Orthopedics · LWJ · Jul 25, 2000 · Orthopedic

Device Facts

• Record ID: K001942
• Device Name: SL-PLUS AND SLR-PLUS STEMS
• Applicant: Plus Orthopedics
• Product Code: LWJ · Orthopedic
• Decision Date: Jul 25, 2000
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SL-PLUS® Stem primary component 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. The SLR-PLUS® Stem, a revision component, is also available to replace previously failed femoral hip arthroplasties. Both components can be used with or without cement. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.

Device Story

SL-PLUS® and SLR-PLUS® are femoral stems for total hip arthroplasty; double-taper design; manufactured from Ti-6Al-7Nb titanium alloy. Primary stem (SL-PLUS®) available in 14 sizes; revision stem (SLR-PLUS®) available in 11 sizes. Compatible with CoCrMo alloy femoral heads (22, 28, 32 mm diameters) or INTRAPLANT ceramic heads. Used by orthopedic surgeons in clinical settings to replace diseased/traumatized femoral head/neck or failed prior arthroplasties. Implanted with or without bone cement to relieve hip pain and restore joint motion.

Clinical Evidence

Bench testing only. Biomechanical testing performed to confirm suitability for in vivo loading.

Technological Characteristics

Double-taper femoral stem design. Materials: Ti-6Al-7Nb titanium alloy (ASTM F136-98) for stems; CoCrMo alloy (ASTM F799-99) for femoral heads. Available in multiple sizes and lengths. Cementless or cemented application.

Indications for Use

Indicated for patients requiring total hip arthroplasty due to disease or trauma of the femoral head and neck, or for revision of failed femoral hip arthroplasties. Contraindications: acute/chronic local or systemic infections; serious lesions of muscles, nerves, or blood vessels; bony defects or poor bone quality endangering stability; concurrent disease interfering with implant function.

Regulatory Classification

Identification

A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.

Predicate Devices

• SL-PLUS® and SLR-PLUS® Stems (K932481)

Reference Devices

• PLUS Unipolar CoCrMo (K990309)
• PLUS Bipolar CoCrMo (K982447)
• INTRAPLANT Ceramic Head Prosthesis (K990261)

Submission Summary (Full Text)

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Koo1942

K001942 Special 510(k) SL-PLUS® and SLR-PLUS® Stems July 10, 2000

## 510(k) Summary of Safety and Effectiveness

JUL 2 5 2000

- Hartmut Loch, C.E.O. Contact: PLUS ORTHOPEDICS 3550 General Atomics Ct., Bldg. 15-100 San Diego, CA 92121 Tel: [phone]
SL-PLUS® and SLR-PLUS® Stems Trade name:

Total Hip Joint, Femoral Component, Cementless Common name:

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

SL-PLUS® and SLR-PLUS® Stems, K932481, S/E 06/08/94 Equivalence:

The SL-PLUS® and SLR-PLUS® Femoral Stems are of a double taper Characteristics: design and are manufactured from Ti-6AI-7Nb titanium alloy according to ASTM F136-98. The primary stem SL-PLUS® is available in 14 sizes ranging from size 01 through 12. The SLR-PLUS® revision stem is available in 11 sizes ranging from size 1 through 11. The femoral ball heads are manufactured from CoCrMo alloy according to ASTM F799-99. They are available in 22 mm, 28 mm, and 32 mm diameters and five different lengths, namely small (S), medium (M), long (L), extra long (XL) and extra-extra long (XXL). In addition, the INTRAPLANT ceramic ball heads with 28 mm and 32 mm diameter may be used with the SL-PLUS® and SLR-PLUS® stems. PLUS Unipolar CoCrMo, K990309, S/E/ 3/15/99 PLUS Bipolar CoCrMo, K982447, S/E/ 11/25/98

INTRAPLANT Ceramic Head Prosthesis, K990261, S/E 8/27/99.

The SL-PLUS® Stem primary component is intended for treating patients Indications: who are candidates for total hip arthroplasty because the natural femoral head and neck has been subject to disease or trauma. The SLR-PLUS® Stem, a revision component, is also available to replace previously failed femoral hip arthroplasties. Both components can be used with or without cement. 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 Testing has been done. All test results are sufficient for in Performance data: vivo loading.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 5 2000

Mr. Hartmut Loch Chief Executive Officer Plus Orthopedics Building 15-100 3550 General Atomics Court San Diego, California 92121-1122

Re: K001942

Trade Name: SL-Plus® and SLR-Plus® Stems Regulatory Class: II Product Code: LWJ and JDI Dated: June 23, 2000 Received: June 26, 2000

Dear Mr. Loch:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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## Page 2 - Mr. Hartmut Loch

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Donna R. Lochner

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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K001942 Special 510(k) SL-PLUS® and SLR-PLUS® Stems July 10, 2000

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## 510(k) Number (if known): K001942

Device Name: SL-PLUS® and SLR-PLUS® Stems

Indications for Use:

The SL-PLUS® Stem primary component 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. The SLR-PLUS® Stem, a revision component, is also available to replace previously failed femoral hip arthroplasties. Both components can be used with or without cement. 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 NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Duane R. Vochines.

Ivision Sign-Off-Off-Off-Off-Clices 510(k) Number .

Prescription Use (Per 21 CFR 801.109)

OR

NO Over-The-Counter-Use (Optional Format 1-2-96)