(29 days)
Not Found
No
The document describes a mechanical prosthetic device and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is intended to reduce pain and improve function and mobility in patients with painful arthritic joints or pathological fractures, which are therapeutic goals.
No
The device is an orthopedic implant (Total Elbow System) used for joint replacement, not for diagnosing medical conditions. Its purpose is to treat painful arthritic joints and pathological fractures.
No
The device description clearly outlines physical components made of polyethylene and metal, indicating it is a hardware medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the Acclaim™ Total Elbow System is a replacement hinge pin assembly for a total elbow replacement system. It is a physical implant used within the body.
- Intended Use: The intended use is to reduce pain and improve function of the elbow joint in patients with arthritis or fractures. This is a therapeutic and structural intervention, not a diagnostic test performed on a sample.
The device is an implantable medical device used for orthopedic surgery.
N/A
Intended Use / Indications for Use
The Acclaim™ Total Elbow System is indicated to reduce pain and improve the function and mobility of the affected joint in patients with a painful arthritic joint due to osteoarthritis, theumatoid arthritis, or post traumatic arthritis and pathological fractures of the distal humerus in which adequate bone stock exists for the fixation of prosthetic components.
Total Elbow replacement may be considered for younger patients, if, in the opinion of the surgeon, an unequivocal indication for elbow replacement outweighs the risks associated with the age of the patient, and if limited demands regarding activity and elbow joint loading can be assured. This included patients for whom an immediate gain of elbow mobility may lead to an expectation of significant improvement in the quality of their lives.
The Acclaim™ Total Elbow System is intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JDC, JDB
Device Description
The Acclaim™ Total Elbow System replacement hinge pin assembly is designed as a replacement of a linked (constrained) elbow hinge pin assembly due to hinge pin disassociation. When the Acclaim Total Elbow System is implanted as a linked system. it is held together with the linked ulnar component and pin assembly, and is used when there is poor bone stock.
The Acclaim™ Total Elbow System replacement hinge pin assembly is comprised of a polyethylene humeral yoke and locking sleeve, with a metal locking pin, ulnar bearing, ulnar bearing screw, washer, and wire. The replacement hinge pin assembly is used in conjunction with well-fixed humeral and ulnar components.
Acclaim™ Total Elbow System replacement hinge pin assembly design includes modifications to the ulnar bearing, polyethylene sleeve, and locking pin. In addition, a washer and cross-pin locking mechanism has been included to the assembly using the same design as the Mark II Total Elbow System locking mechanism, previously cleared in K872084 dated June 25, 1987.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Elbow
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.
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
060696 p.
APR 1 4 2006
Summary Acclaim™ Total Elbow System
| 510(k) SUMMARY | |
|---|---|
| NAME OF FIRM: | DePuy Orthopaedics, Inc. |
| 700 Orthopaedic Drive | |
| Warsaw, IN 46580 | |
| 510(K) CONTACT: | Natalie S. Heck |
| Manager, Regulatory Affairs | |
| DePuy Orthopaedics, Inc. | |
| PO Box 988 | |
| 700 Orthopaedic Drive | |
| Warsaw, IN 46581-0988 | |
| TRADE NAME: | Acclaim™ Total Elbow System |
| COMMON NAME: | Elbow Prosthesis |
| CLASSIFICATION: | When used as a semi-constrained (unlinked elbow), it is |
| a Class II device per 21 CFR §888.3160 | |
| When used as a constrained (linked), it is a Class II | |
| device per 21 CFR §888.3150 | |
| DEVICE PRODUCT CODE: | 87 JDB - Prosthesis, Elbow, Semi-Constrained, |
| Cemented (Class II) | |
| 87 JDC - Prosthesis, Elbow, Constrained, Cemented | |
| (Class II) | |
| SUBSTANTIALLY EQUIVALENT | |
| DEVICES: | Acclaim™ Total Elbow System - K992656 |
| (formerly cleared as DePuy Total Elbow System) | |
| Mark II Elbow System - K872084 |
DEVICE DESCRIPTION:
C. Indications for Use:
The Acclaim™ Total Elbow System is indicated to reduce pain and improve the function and mobility of the affected joint in patients with a painful arthritic joint due to osteoarthritis, theumatoid arthritis, or post traumatic arthritis and pathological fractures of the distal humerus in which adequate bone stock exists for the fixation of prosthetic components.
Total Elbow replacement may be considered for younger patients, if, in the opinion of the surgeon, an unequivocal indication for elbow replacement outweighs the risks associated with the age of the patient, and if limited demands regarding activity and elbow joint loading can be assured. This included patients for whom an immediate gain of elbow
0000006
1
mobility may lead to an expectation of significant improvement in the quality of their lives.
KO66666
The Acclaim™ Total Elbow System is intended for cemented use only.
D. Device Description:
The Acclaim™ Total Elbow System replacement hinge pin assembly is designed as a replacement of a linked (constrained) elbow hinge pin assembly due to hinge pin disassociation. When the Acclaim Total Elbow System is implanted as a linked system. it is held together with the linked ulnar component and pin assembly, and is used when there is poor bone stock.
The Acclaim™ Total Elbow System replacement hinge pin assembly is comprised of a polyethylene humeral yoke and locking sleeve, with a metal locking pin, ulnar bearing, ulnar bearing screw, washer, and wire. The replacement hinge pin assembly is used in conjunction with well-fixed humeral and ulnar components.
Acclaim™ Total Elbow System replacement hinge pin assembly design includes modifications to the ulnar bearing, polyethylene sleeve, and locking pin. In addition, a washer and cross-pin locking mechanism has been included to the assembly using the same design as the Mark II Total Elbow System locking mechanism, previously cleared in K872084 dated June 25, 1987.
E. Substantial Equivalence:
The substantial equivalence of the Acclaim™ Total Elbow System replacement hinge pin assembly is substantiated by its similarity in indications for use, design, materials, sterilization and packaging to the current Acclaim™ Total Elbow (formerly cleared as DePuy Total Elbow System, K992656), DePuy Mark II Elbow (K872084) hinge pin assemblies.
The determination of substantial equivalence for this device was based on a detailed device description, and conformance with voluntary performance standards.
2
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. In the center of the seal is a stylized image of three human figures, representing the department's mission to protect the health of all Americans and provide essential human services.
APR 1 4 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DePuy Orthopaedics, Inc. c/o Ms. Natalie S. Heck Manager, Regulatory Affairs P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re: K060696
Trade/Device Name: Acclaim Total Elbow System Regulation Number: 21 CFR 888.3150 Regulation Name: Elbow joint metal/polymer constrained cemented prosthesis Regulatory Class: Class II Product Codes: JDC, JDB Dated: March 15, 2006 Received: March 16, 2006
Dear Ms. Heck:
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 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.
3
Page 2 - Ms. Natalie S. Heck
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/industry/support/index.html.
Sincerely yours.
. Melli
Mark N. Melkerson 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): K0606 Device Name: Acclaim™ Total Elbow System
Indications for Use:
The Acclaim™ Total Elbow System is indicated to reduce pain and improve the function and mobility of the affected joint in patients with a painful arthritic joint due to osteoarthritis, theumatoid arthritis, or post traumatic arthritis and pathological fractures of the distal humerus in which adequate bone stock exists for the fixation of prosthetic components.
Total Elbow replacement may be considered for younger patients, if, in the opinion of the surgeon, an unequivocal indication for elbow replacement outweighs the risks associated with the age of the patient , and if limited demands regarding activity and elbow joint loading can be assured. This included patients for whom an immediate gain of elbow mobility may lead to an expectation of significant improvement in the quality of their lives.
The Acclaim™ Total Elbow System is intended 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 CDRH, Office of Device Evaluation (ODE)
el mal
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
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510(k) Number_ko60696
0000004