OSS LES PROXIMAL FEMORAL COMPONENT

• K Number: K021380
• Device Name: OSS LES PROXIMAL FEMORAL COMPONENT
• Manufacturer: BIOMET, INC.
• Date Cleared: 2002-05-28 ( 27 days)
• Product Code: JDI
• Regulation Number: 888.3350

Intended Use

The OSS Les Proximal Femoral Component is indicated for treatment of patients that require proximal femoral, or total femur replacement for one of the following: 1) Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis 2) Correction of varus, valgus or post traumatic deformity 3) Correction of revision of unsuccessful ostoetomy, arthrosis, or previous joint replacement 4) Ligament deficiencies 5) Tumor resections 6) Treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques 7) Revision of previously failed total joint arthroplasty 8) Trauma This device is a single use implant.

Device Description

The OSS Les Proximal Femoral Component is designed for use with Biomet's Oncology Salvage System. It may be used either for proximal femoral replacement with a diaphyseal segments and intramedullary stem or as part of a total femur replacement with a segmental distal femur component and the appropriate hinged knee components. The OSS Les Proximal Femeral Component combines features of the three styles of Proximal Femoral Components contained in 510(k) K002757.

Predicate Devices

K002757

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a mechanical implant for orthopedic surgery and makes no mention of AI or ML technology.

Therapeutic

Yes
The device is indicated for the "treatment of patients that require proximal femoral, or total femur replacement," addressing various medical conditions such as painful joints, deformities, and tumor resections, which signifies a therapeutic purpose.

Diagnostic

No

Explanation: The device is an orthopedic implant for replacing parts of the femur, not for diagnosing medical conditions. Its intended use includes treating various joint conditions, correcting deformities, and addressing trauma or tumor resections, all of which are treatment-oriented rather than diagnostic.

SaMD (Software as a Medical Device)

No

The device description clearly indicates it is a physical implant (proximal femoral component) designed for surgical use, not a software application.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
• Device Description: The provided description clearly states that the OSS Les Proximal Femoral Component is a single use implant designed for proximal femoral or total femur replacement. This means it is a device that is surgically placed inside the body.
• Intended Use: The intended uses listed are all related to surgical procedures and the replacement of bone structures within the body.

Therefore, based on the description and intended use, this device is an implantable medical device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The OSS Les Proximal Femoral Component is indicated for treatment of patients that require proximal femoral, or total femur replacement for one of the following:

• 1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis
• 2. Correction of varus, valgus or post traumatic deformity
• 3. Correction of revision of unsuccessful ostoetomy, arthrosis, or previous joint replacement
• 4. Ligament deficiencies
• 5. Tumor resections
• 6. Treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
• 7. Revision of previously failed total joint arthroplasty
• 8. Trauma

Product codes (comma separated list FDA assigned to the subject device)

JDI, LPH

Device Description

The OSS Les Proximal Femoral Component is designed for use with Biomet's Oncology Salvage System. It may be used either for proximal femoral replacement with a diaphyseal segments and intramedullary stem or as part of a total femur replacement with a segmental distal femur component and the appropriate hinged knee components.

The OSS Les Proximal Femoral Component combines features of the three styles of Proximal Femoral Components contained in 510(k) K002757.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

proximal femoral, total femur

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Testing: Engineering analysis has shown the modified device to have similar characteristics to predicate devices and no new risks are envisioned.

Clinical Testing: None provided

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K002757

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
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).(b)
Classification. Class II.

Summary

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MAY 2 8 2002

Image /page/0/Picture/1 description: The image shows the logo for Biomet Corporate Headquarters. The logo consists of the word "BIOMET" in a stylized font, with the letters connected to each other. Below the logo, the words "CORPORATE HEADQUARTERS" are printed in a smaller, sans-serif font. The text is centered below the logo.

K0d21380
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Summary of Safety and Effectiveness

| Applicant/Sponsor: | Biomet Orthopedics, Inc.
P.O. Box 587
Warsaw, Indiana 46581-0587 |

--------------------	------------------------------------------------------------------------

• Contact Person: Patricia Sandborn Beres Biomet Orthopedics, Inc. 56 Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587 Phone: [phone] extension 1278 Fax: [phone]
  Proprietary Name: OSS Les Proximal Femoral Component

Classification Name: Prosthesis, Hip, semi-constrained, metal/polymer, cemented (888.3350) and Prosthesis, Hip, semi-constrained, metal/polymer, uncemented (888.3358) - when used as proximal femoral

Legally Marketed devices to Which Substantial Equivalence is Claimed: Proximal Femoral Components previously cleared in 510(k) K002757 for the Oncology Salvage System.

Device Description: The OSS Les Proximal Femoral Component is designed for use with Biomet's Oncology Salvage System. It may be used either for proximal femoral replacement with a diaphyseal segments and intramedullary stem or as part of a total femur replacement with a segmental distal femur component and the appropriate hinged knee components.

The OSS Les Proximal Femoral Component combines features of the three styles of Proximal Femoral Components contained in 510(k) K002757.

MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

OFFICE 219.267.6639

FAX [phone]

E-MAIL [e-mail]

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021380
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Indications For Use: The OSS Les Proximal Femoral Component is indicated for treatment of patients that require proximal femoral, or total femur replacement for one of the following:

• 1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis
• 2. Correction of varus, valgus or post traumatic deformity
• 3. Correction of revision of unsuccessful ostoetomy, arthrosis, or previous joint replacement
• 4. Ligament deficiencies
• 5. Tumor resections
• 6. Treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
• 7. Revision of previously failed total joint arthroplasty
• 8. Trauma

Summary of Technologies: The materials, surface finishes, and processing of the OSS Les Proximal Femoral Component are similar to the predicate devices.

Non-Clinical Testing: Engineering analysis has shown the modified device to have similar characteristics to predicate devices and no new risks are envisioned.

Clinical Testing: None provided

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 8 2002

Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet. Inc. P.O. Box 587 Warsaw, IN 46581-0587

Re: K021380

Trade Name: OSS Les Proximal Femoral Component Regulation Number: 21 CFR 888.3350 and 888.3358 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis

Regulatory Class: Class II Product Code: JDI and LPH Dated: April 24, 2002 Received: May 1, 2002

Dear Ms. Sandborn Beres:

We have reviewed your Section 510(k) premarket 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 May 20, 1970, the enabilities and of the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, (Treefore, market the device, subject to the general controls provisions of the Act. The general thereofs, maintons 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 11 your device 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 r load be actived a determination that your device complies with other requirements of the Act that I Dr Has Intatutes and regulations administered by other Federal agencies. You must or uny 1 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 - Ms. Patricia Sandborn Beres

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 premated predicated 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 yours,

R. Mark N. Mdlkess

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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510(k) Number (if known): ├од 1380

Device Name: OSS Les Proximal Femoral Component

Indications For Use:

The OSS Les Proximal Femoral Component is indicated for treatment of patients that require proximal femoral, or total femur replacement.

Indications:

• 1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis
• 2. Correction of varus, valgus or post traumatic deformity
• 3. Correction of revision of unsuccessful ostoetomy, arthrosis, or previous joint replacement
• 4. Ligament deficiencies
• 5. Tumor resections
• 6. Treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
• 7. Revision of previously failed total joint arthroplasty
• 8. Trauma

This device is a single use implant.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

eral. Restorative and Neurological Devices

Over-The-Counter Use

(Optional Format 1-2-96)

510(k) Number K091380