(71 days)
Not Found
No
The provided text describes a mechanical prosthetic device for humeral replacement and does not mention any AI or ML components or functionalities.
Yes
The device is described as a replacement for parts of the humerus due to various debilitating conditions (e.g., bone neoplasms, severe arthritis, fractures), indicating its role in treating or rehabilitating patients.
No
This device is a prosthetic system intended for the replacement of portions of the humerus, typically in cases requiring extensive resection due to various conditions like bone neoplasms, severe trauma, or degenerative joint diseases. It is a treatment device, not a diagnostic one.
No
The device description clearly indicates it is a system of physical components designed for surgical implantation to replace parts of the humerus, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. Examples include blood tests, urine tests, and genetic tests.
- Device Description and Intended Use: The provided text clearly describes a device intended for surgical implantation to replace parts of the humerus bone. It is a prosthetic device used in the treatment of various conditions affecting the humerus.
- Lack of In Vitro Activity: There is no mention of this device being used to examine specimens outside the body. Its function is to physically replace bone tissue within the patient's body.
Therefore, based on the provided information, the LPS Upper Extremity is a surgical implant/prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JDC, KWT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal, mid-shaft or intercalary portion, distal and/or total humerus
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)
Not Found
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.
K992065, K020045, K033280, K992656
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
§ 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.”
0
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 and | |
| Regulatory Class: | Prosthesis, shoulder, non-constrained, metal/polymer |
| cemented: Class II per 21 CFR §888.3650 | |
| Elbow joint metal/polymer constrained cemented | |
| prosthesis: Class II per 21 CFR §888.3150 |
87 KWT, 87 JDC Product Code:
C. Indications for Use:
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.
1
- Severe trauma requiring extensive resection and replacement .
The LPS Upper Extremity components are for CEMENTED USE ONLY.
D. 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.
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).
2
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
3
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
4
Indications for Use 510(k) Number (if known): _ KO 42664 Device Name: LPS Upper Extremity
Indications for Use:
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.
| Prescription Use | X (Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use | (21 CFR 807 Subpart C) |
|---|---|---|---|---|
| ------------------ | ------------------------------- | -------- | ---------------------- | ------------------------ |
(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 |