PLUS-FIT ACETABULAR CUP

K973077 · Plus Orthopedics · LWJ · Nov 13, 1997 · Orthopedic

Device Facts

• Record ID: K973077
• Device Name: PLUS-FIT ACETABULAR CUP
• Applicant: Plus Orthopedics
• Product Code: LWJ · Orthopedic
• Decision Date: Nov 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PLUS-FIT Acetabular Cup is intended for all types of arthrosis, such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to acetabular revisions. In normal cases, however, the surgeon will use an acetabular implant one size larger and in exceptional cases two sizes larger.

Device Story

PLUS-FIT Acetabular Cup is a cementless, metal/polymer/metal semi-constrained porous-coated acetabular component for total hip arthroplasty. Device features triple-radius profile designed for minimal bone resection and press-fit fixation. Physiological load transfer occurs through peripheral acetabular zone, providing primary stability without screw fixation and promoting osseous integration. Used by orthopedic surgeons in clinical settings for hip joint replacement or revision. Surgeon selects implant size based on patient anatomy, typically one to two sizes larger than standard in revision cases. Device provides stable acetabular foundation for hip joint reconstruction, aiming to restore joint function and alleviate pain associated with arthrosis or trauma.

Clinical Evidence

No clinical data. Evidence consists of biomechanical laboratory testing comparing the PLUS-FIT Acetabular Cup to leading competitive cementless acetabular cups. Results indicated the device was comparable to or exceeded the performance of predicate/competitive devices.

Technological Characteristics

Cementless acetabular cup; metal/polymer/metal construction; porous-coated; triple-radius profile; press-fit design; physiological load transfer mechanism. No software or electronic components.

Indications for Use

Indicated for patients with hip joint arthrosis (degenerative, post-traumatic, rheumatoid), femoral head fracture, avascular necrosis, or sequelae of prior hip surgeries (fixation, reconstruction, arthrodesis, hemiarthroplasty, total hip replacement) requiring acetabular revision. Contraindicated in patients with acute/chronic local or systemic infections, serious muscle/nerve/vessel lesions, poor bone quality/defects, or concurrent diseases 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

• RIMFIX Cup (K-Number unknown)

Submission Summary (Full Text)

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K973077

NOV 1 3

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## 510(k) Summary of Safety and Effectiveness Information

(as required by 807.92c), prepared by Hartmut Loch, President of HHL Consulting for PLUS Orthopedics in San Diego, California August 14, 1997

PLUS-FIT Acetabular Cup Trade name:

Cementless Total Hip Prosthesis, Acetabular Component Common name:

Hip joint metal/polymer/metal semi constrained porous Classification name: coated uncemented prosthesis

We are claiming substantial equivalency to the cementless RIMFIX Equivalence: Cup, marketed by Surgical Implants, Inc., Sarasota, Florida (K-Number unknown).

The PLUS-FIT Acetabular Cup is a cementless acetabular cup, Characteristics: which was designed with a triple-radius profile. The advantages are 1) minimal bone resection, 2) press-fit with physiological load transfer through the peripheral zone of the acetabulum, thus ensuring good primary stability without the need for screw fixation and 3) optimal osseous integration due to good primary stability.

The PLUS-FIT Acetabular Cup is intended for all types of arthrosis, Indications: such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to acetabular revisions. In normal cases, however, the surgeon will use an acetabular implant one size larger and in exceptional cases two sizes larger.

Contraindications include acute or chronic infections (local or Contraindications: systemic), 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.

Performance data: Biomechanical laboratory tests were performed comparing cups of other leading manufacturers to the PLUS-FIT Acetabular Cup. All tests showed that the PLUS-FIT Acetabular Cup was comparable to, or exceeded, cementless competitive acetabular cups.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 3 1997

Mr. Hartmut Loch ·President HHL Consulting Representing Plus Orthopedics 835 Cortez Lane Foster City, California 94404

Re: K973077 PLUS-FIT Acetabular Cup Trade Name: Requlatory Class: II Product Code: LWJ Dated: October 24, 1997 Received: October 27, 1997

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 controls provisions The general controls provisions of the Act 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 requlations 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 requlations.

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Page 2 - Mr. Hartmut Loch

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.

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 [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Enclosure

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Page 1 of of 1 a

12 21 PH 197 KS73077 Aug 18 510(k) Number (if known):

Device Name: _____PLUS-FIT ACETABULAR CUP

Indications for Use:

The PLUS-FIT Acetabular Cup is intended for all types of arthrosis, such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to acetabular revisions. In normal cases, however, the surgeon will use an acetabular implant one size larger and in exceptional cases two sizes larger.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

t.co/xeep

510(k) Number

Prescription Use ਮ (Per 21 CFR 801.109)

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OR

Over-The-Counter Use

(Optional Format 1-2-96