The LPS Upper Extremity is intended for use in replacement of the proximal, mid-shaft or intercalary portion, distal and/or total humerus. This system is especially designed for cases that require extensive resection and restoration. Specific diagnostic indications for use include:

Primary bone neoplasnms (e.g., osteosarcomas, chondrosarcomas, Ewing's sarcomas) requiring extensive resection(s) and replacement(s) of the proximal and/or distal humerus;
Metastatic bone disease and pathologic fractures with extensive bone loss or where other forms of treatment such as internal fixation are inadequate;
Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (JD), e.g., rheumatoid arthritis, requiring extensive resection and replacement of the proximal and/or distal humerus;
Patients suffering from congential or acquired deformity, such as post-traumatic deformity and/or arthritis;
Communited fractures of the proximal, distal and/or humeral shaft where forms of fixation are indadequate;
Persistent humeral fracture non-union;
Patients suffering from severe cuff tear arthropathy that does not respond to any conservative therapy or better alternative surgical treatment;
Revision shoulder or elbow arthroplasty cases requiring extensive resection(s) and replacements of the proximal, distal or total humerus.
Severe trauma requiring extensive resection and replacement.
The LPS Upper Extremity components are for CEMENTED USE ONLY.

Device Description

The LPS Upper Extremity components are designed for the replacement of the mid-shaft or intercalary portion of the humerus, proximal, distal and/or total humerus. Unlike primary shoulder and elbow systems, this system is used when the amount of resection and restoration is extreme (e.g. in oncology cases, end-stage revision). A total humeral replacement is possible in those cases where no part of the humerus can be salvaged.

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria, device performance results, or any study conducted to prove the device meets specific criteria. The document is a 510(k) summary for the 'LPS Upper Extremity' device, which outlines its indications for use, device description, and substantial equivalence to previously cleared devices. It does not include details on clinical trials, performance testing, sample sizes, expert ground truth establishment, or any comparative effectiveness studies. Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving the device meets them based on the given information.

Summary

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DEC - 8 2004

510(k) Summary LPS Upper Extremity

DePuy, Inc. 700 Orthopaedic Drive Warsaw, IN 46581

A. Contact Person:

Tiffani Rogers Regulatory Affairs Associate (574) 371-4927

B. Device Information:

Proprietary Name:	LPS Upper Extremity
Common Name:	Shoulder prosthesis; Elbow prosthesis
Classification Name andRegulatory Class:	Prosthesis, shoulder, non-constrained, metal/polymercemented: Class II per 21 CFR §888.3650Elbow joint metal/polymer constrained cementedprosthesis: Class II per 21 CFR §888.3150

87 KWT, 87 JDC Product Code:

C. Indications for Use:

Primary bone neoplasnms (e.g., osteosarcomas, chondrosarcomas, Ewing's sarcomas) requiring . extensive resection(s) and replacement(s) of the proximal and/or distal humerus;
Metastatic bone disease and pathologic fractures with extensive bone loss or where other forms . of treatment such as internal fixation are inadequate;
- Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular . necrosis, osteoarthritis, and inflammatory joint disease (JD), e.g., rheumatoid arthritis, requiring extensive resection and replacement of the proximal and/or distal humerus;
- Patients suffering from congential or acquired deformity, such as post-traumatic deformity . and/or arthritis;
- Communited fractures of the proximal, distal and/or humeral shaft where forms of fixation . are indadequate;
- . Persistent humeral fracture non-union;
- Patients suffering from severe cuff tear arthropathy that does not respond to any conservative . therapy or better alternative surgical treatment;
- Revision shoulder or elbow arthroplasty cases requiring extensive resection(s) and . replacements of the proximal, distal or total humerus.

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Severe trauma requiring extensive resection and replacement .
The LPS Upper Extremity components are for CEMENTED USE ONLY.

D. Device Description:

E. Substantial Equivalence:

The substantial equivalence of the LPS Upper Extremity is substantiated by its similarity in indications for use, design, materials, sterilization and packaging to the Global Advantage Total Shoulder system (K992065, cleared July 12, 1999), the Biomet Orthopedic 3-piece Proximal Humeral Replacement System (K020045, cleared January 30, 2002), the Biomet Orthopaedic Discovery Elbow - Mosaic Distal Humeral Replacement System (K033280, cleared December 19, 2003) and the Acclaim Elbow, cleared as the DePuy Total Elbow (K992656, cleared November 05, 1999).

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 8 2004

Ms. Tiffani D. Rogers Regulatory Affairs Associate DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K042664

Trade/Device Name: LPS Upper Extremity Regulation Numbers: 21 CFR 888.3150, 21 CFR 888.3650 Regulation Names: Elbow joint metal/polymer constrained cemented prosthesis, Shoulder joint metal/polymer non-constrained cemented prosthesis Regulatory Class: II Product Codes: JDC, KWT Dated: September 23, 2004 Received: September 28, 2004

Dear Ms. Rogers:

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

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Page 2 - Ms. Tiffani D. Rodgers

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.

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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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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Indications for Use 510(k) Number (if known): _ KO 42664 Device Name: LPS Upper Extremity

Indications for Use:

Primary bone neoplasnms (e.g., osteosarcomas, chondrosarcomas, Ewing's sarcomas) . requiring extensive resection(s) and replacement(s) of the proximal and/or distal humerus;
Metastatic bone disease and pathologic fractures with extensive bone loss or where other . forms of treatment such as internal fixation are inadequate;

Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular . necrosis, osteoarthritis, and inflammatory joint disease (JD), e.g., rheumatoid arthritis, requiring extensive resection and replacement of the proximal and/or distal humerus;

Patients suffering from congential or acquired deformity, such as post-traumatic deformity . and/or arthritis;

Communited fractures of the proximal, distal and/or humeral shaft where forms of fixation . are indadequate;

Persistent humeral fracture non-union; �

Patients suffering from severe cuff tear arthropathy that does not respond to any conservative . therapy or better alternative surgical treatment;

Revision shoulder or elbow arthroplasty cases requiring extensive resection(s) and . replacements of the proximal, distal or total humerus.

Severe trauma requiring extensive resection and replacement .

The LPS Upper Extremity components are for CEMENTED USE ONLY.

Prescription Use	X (Part 21 CFR 801 Subpart D)	AND/OR	Over-The-Counter Use	(21 CFR 807 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of GDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

Page	of
510(k) Number	K042664

Regulation Number and Section

§ 888.3150 Elbow joint metal/polymer constrained cemented prosthesis.

(a)
Identification. An elbow joint metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. It is made of alloys, such as cobalt-chromium-molybdenum, or of these alloys and of an ultra-high molecular weight polyethylene bushing. The device prevents dislocation in more than one anatomic plane and consists of two components that are linked together. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,”
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra High Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,”
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(viii) ISO 14630:1997 “Non-active Surgical Implants—General Requirements,”
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 981-93 “Practice for Assessment of Compatibility of Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,”
(v) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(vi) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vii) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings, ” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”