MODIFICATION TO ONCOLOGY SALVAGE SYSTEM (OSS)

• K Number: K020970
• Device Name: MODIFICATION TO ONCOLOGY SALVAGE SYSTEM (OSS)
• Manufacturer: BIOMET, INC.
• Date Cleared: 2002-04-04 ( 9 days)
• Product Code: JDI , KRO
• Regulation Number: 888.3350
• Type: Special
• Panel: Orthopedic
• Reference & Predicate Devices: K002757
• Predicate For: N/A

Intended Use

The Oncology Salvage System offers a variety of component options for treatment of patients that require proximal femoral, distal femoral, total femur, or proximal tibial replacements, as well as, resurfacing components for the proximal tibial and distal femur.

Indications:

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

These devices are single use implants.

These devices are for cemented use only.

Device Description

The Biomet® Oncology Salvage System offers a variety of component options for treatment of patients that require proximal femoral, total femur, or proximal tibial replacements, as well as, resurfacing components for the proximal tibial and distal femur.

There are twelve diaphyseal segment lengths available in 3cm, 4cm, and 5cm to 23 cm in 2cm increments. The diaphyseal segments are machined from wrought Ti-6AI-4V (ASTM F-1472). All the segments have a smooth satin finish.

AI/ML Overview

This document describes a 510(k) premarket notification for the Biomet® Oncology Salvage System Diaphyseal Segments (OSS-K). It is a medical device submission seeking clearance, not a study evaluating device performance against acceptance criteria in the typical sense of a clinical trial.

Therefore, many of the requested categories are not applicable to this type of regulatory submission. The submission aims to demonstrate "substantial equivalence" to a predicate device rather than fulfilling specific performance acceptance criteria through clinical studies.

Here's a breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (for 510(k) Substantial Equivalence)	Reported Device Performance
Technological Characteristics: Similar to or identical to predicate device materials, design, sizing, and indications.	The device's technological characteristics (materials, design, sizing, and indications) are similar to or identical to the predicate device.
Non-Clinical Testing: Sufficient to establish substantial equivalence.	Surface finish analysis and mathematical calculations were performed to establish substantial equivalence.
Clinical Testing: Not required if substantial equivalence can be established otherwise.	None provided as a basis for substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. This submission is for regulatory clearance based on substantial equivalence to a predicate device, not a performance study with a test set in the clinical or AI context. The non-clinical testing involved surface finish analysis and mathematical calculations, but no "test set" of patients or data, as typically defined for performance studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. No ground truth establishment by experts for a test set was described as this is a 510(k) submission based on substantial equivalence, not a clinical performance study requiring expert adjudication of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No test set or expert adjudication method was used for this 510(k) submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This device is a surgical implant (prosthesis components), not an AI-assisted diagnostic tool. Therefore, an MRMC study is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable. The "ground truth" for this 510(k) submission is the demonstration of substantial equivalence to the legally marketed predicate device (Biomet® Oncology Salvage System (OSS)- K002757) based on technological characteristics and non-clinical testing, rather than a clinical ground truth established through expert consensus, pathology, or outcomes data for a new performance claim.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/machine learning device or a clinical study for training purposes.

9. How the ground truth for the training set was established

• Not Applicable. As there is no training set, no ground truth needed to be established for one.

Summary

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R = 4 2002

BIOMET
CORPORATE HEADQUARTERS
K020476
page 1

SUMMARY OF SAFETY AND EFFECTIVENESS

Sponsor:	Biomet, Inc.56 East Bell DriveP.O. Box 587Warsaw, IN 46581-0587
Contact Person:	Tracy J. Bickel(574) 267-6639
Proprietary Name:	Biomet® Oncology Salvage System
Common Name:	OSS-K Diaphyseal Segments
Classification Name:	Prosthesis, Hip, semi-constrained, metal/polymer,cemented (888.3350, 87JDI)Prosthesis, Knee, femorotibial, constrained, cemented,metal/polymer (888.3510, 87KRO)

Substantially Equivalent Devices: Oncology Salvage System (OSS)- K002757

The Biomet® Oncology Salvage System offers a variety of component options for Device Description: treatment of patients that require proximal femoral, total femur, or proximal tibial replacements, as well as, resurfacing components for the proximal tibial and distal femur.

There are twelve diaphyseal segment lengths available in 3cm, 4cm, and 5cm to 23 cm in 2cm increments. The diaphyseal segments are machined from wrought Ti-6AI-4V (ASTM F-1472). All the segments have a smooth satin finish.

Intended Use: The Biomet® Oncology Salvage System offers a variety of component options for treatment of patients that require proximal femoral, distal femoral, total femur, or proximal tibial replacements, as well as, resurfacing components for the proximal tibial and distal femur.

Indications:

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

These devices are single use implants.

These devices are for cemented use only

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

1

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

1

OFFICE 219.267.6639

FAX
219.267.8137
0064

E-MAIL [e-mail]

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Biomet, Inc. Summary of Safety and Effectiveness - Page 2 OSS-K Diaphyseal Segments

020970
page 2 of 2

Summary of Technologies: The device's technological characteristics (materials, design, sizing, and indications) are similar to or identical to the predicate device.

Non-Clinical Testing: Surface finish analysis and mathematical calculations were performed to establish substantial equivalence.

Clinical Testing: None provided as a basis for substantial equivalence.

All trademarks are property of Biomet, Inc.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus, which is a traditional symbol of medicine.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR = 4 2002

Ms. Tracy J. Bickel Regulatory Specialist Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, IN 46581-0587

Re: K020970

Trade/Device Name: Oncology Salvage System-K Diaphyseal Segments Regulation Number: 21 CFR 888.3350, 21 CFR 888.3510 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis, Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: Class II Product Code: JDI, KRO Dated: March 25, 2002 Received: March 26, 2002

Dear Ms. Bickel:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your beeemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surved in the encreate) 70 ttg. ... ]
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered pror to rita 2011/2017 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 I ou may , arores or visions 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 de roo is enable 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 rease of acribed 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 or any I vith 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. Tracy Bickel

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis loter will and h your e FDA finding of substantial equivalence of your device to a legally premails in the 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" (21 CFR Part 807.97). regulation on interes, "Historians 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,

for Mark A Milheison

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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Page _ of _

510(k) Number (if known): K020970 Device Name: OSS-k Diaphyseal Segments Indications for Use:

The Oncology Salvage System offers a variety of component options for treatment of patients that require proximal femoral, distal femoral, total femur, or proximal tibial replacements, as well as, resurfacing components for the proximal tibial and distal femur.

Indications:

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

These devices are single use implants.

These devices are for cemented use only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use
(Optional Format 1-2-96)

(Division Sign-Off)

garing

Division of General, Restorative and Neurological Devices

510(k) Number K020970

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.