(70 days)
Not Found
No
The summary describes a mechanical elbow replacement system and does not mention any AI or ML components or functionalities.
Yes
The device is used to treat various medical conditions, including non-inflammatory degenerative joint disease, rheumatoid arthritis, fractures, and for revision procedures when other treatments fail, indicating its therapeutic purpose.
No
Explanation: The device is an elbow replacement system, which is a therapeutic device designed to replace a damaged elbow joint, not to diagnose a condition.
No
The device description clearly outlines physical components like stems, bearings, and other hardware for an elbow replacement system. There is no mention of software as the primary or sole component.
No, 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 and intended use: The provided information clearly describes a surgical implant used to replace a portion of the elbow joint. Its intended uses are related to treating various conditions affecting the elbow joint through surgical intervention.
- Lack of mention of biological samples or testing: There is no mention of the device being used to analyze biological samples or perform any kind of diagnostic test.
Therefore, based on the provided information, the Discovery™ Elbow - Mosaic™ Distal Humeral Replacement System is a medical device, specifically a surgical implant, and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The indications for use for the Discovery™ Elbow - Mosaic™ Distal Humeral Replacement System include:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis
- Revision procedures where other treatments or devices have failed
- Correction of functional deformity
- Treatment of acute and chronic fractures with humeral epicondyle involvement which are unmanageable using other treatment methods
- Oncology applications
This device is intended to be used with bone cement.
Product codes (comma separated list FDA assigned to the subject device)
JDC
Device Description
The Discovery™ Elbow - Mosaic™ Distal Humeral Replacement System is an elbow replacement device designed for use in cases where there is distal humeral bone loss. The device consists of a ulnar stem with a pre-assembled bearing, a distal humeral component which, with a humeral condyle kit, completes the hinge of the elbow, an extramedullary modular distal segment for bone replacement and a intramedullary humeral stem. Soft tissue attachment sleeves and canal cement plugs complete the system.
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)
Non-Clinical Testing/ Clinical Testing: None was provided as a basis of substantial equivalence.
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.
Discovery™ Elbow (K013042), Modified Single Axle Total Elbow (K000683), 3-Piece Proximal Humeral Replacement System (K020045), Short and Long Soft Tissue Attachment Sleeves (K022079)
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
DFC 1 9 2003
BIOMET
K033280
page 1 of 1
510(k) Summary
| Applicant/Sponsor: | Biomet Orthopedics, Inc. |
|---|---|
| Contact Person: | Patricia Sandborn Beres |
| Senior Regulatory Specialist | |
| Proprietary Name: | Discovery™ Elbow - Mosaic™ Distal Humeral Replacement System |
| Common Name: | Elbow Prosthesis |
| Classification Name: | Elbow joint metal/polymer constrained cemented prosthesis (888.3150) |
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
- Discovery™ Elbow (K013042) .
- Modified Single Axle Total Elbow (K000683) .
- 3-Piece Proximal Humeral Replacement System (K020045) .
- Short and Long Soft Tissue Attachment Sleeves (K022079) .
Device Description: The Discovery™ Elbow - Mosaic™ Distal Humeral Replacement System is an elbow replacement device designed for use in cases where there is distal humeral bone loss. The device consists of a ulnar stem with a pre-assembled bearing, a distal humeral component which, with a humeral condyle kit, completes the hinge of the elbow, an extramedullary modular distal segment for bone replacement and a intramedullary humeral stem. Soft tissue attachment sleeves and canal cement plugs complete the system.
Indications for Use:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 1.
-
- Rheumatoid arthritis.
-
- Revision where other devices or treatments have failed.
-
- Correction of functional deformity.
- ട്. Treatment of acute or chronic fractures with humeral epicondyle involvement, which are unmanageable using other treatment methods.
- ୍. Oncology applications.
Summary of Technologies: The Discovery™ Elbow - Mosaic™ Distal Humeral Replacement System components (materials, design, sizes and indications), are similar or identical to the predicate devices.
Non-Clinical Testing/ Clinical Testing: None was provided as a basis of substantial equivalence.
All trademarks are property of Biomet, Inc.
75 MAILING ADDRESS SHIPPING ADDRESS P.O. Box 587 56 E. Bell Drive Warsaw, IN 46581-0587 Warsaw, IN 46582 ()1-FICE FAX 19-11411. 1 574.267.6639
574.267.8137
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines emanating from its body, enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 9 2003
Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Orthopedics Corp. P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K033280
Trade/Device Name: Discovery Elbow – Mosaic Distal Humeral Replacement System Regulation Number: 21 CFR 888.3150 Regulation Name: Flbow joint metal/polymer constrained cemented prosthesis Regulatory Class: Class II Product Code: JDC Dated: October 9, 2003 Received: October 10, 2003
Dear Ms. Beres:
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. 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
2
Page 2 - Ms. Beres
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 (301) 594-4659. 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,
Sincerely yours,
for Mark A. Millerson
Celia M. Witten, Ph.D., M.D. Division Director Division of General, Restorative, And Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name: Discovery™ Elbow - Mosaic™ Distal Humeral Replacement System
Indications For Use:
The indications for use for the Discovery™ Elbow - Mosaic™ Distal Humeral Replacement System include:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis
-
- Revision procedures where other treatments or devices have failed
-
- Correction of functional deformity
-
- Treatment of acute and chronic fractures with humeral epicondyle involvement which are unmanageable using other treatment methods
-
- Oncology applications
This device is intended to be used with bone cement.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Mark N. Mullerraro
ion of General, Restorative
d Neurological D...
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