(65 days)
No
The document describes a mechanical hip replacement device and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is indicated for use in Total Hip Replacement to treat various conditions, which is a therapeutic intervention.
No
Explanation: The device is a total hip replacement system, indicated for surgical implantation to treat various hip conditions, not for diagnosing them. Its description focuses on its components and their use in arthroplasty, not on diagnostic functions.
No
The device description clearly describes physical components (taper inserts, modular heads) intended for surgical implantation, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided text describes a device that is surgically implanted into the body as part of a total hip replacement. It is a physical component used to replace damaged parts of the hip joint.
- Intended Use: The intended use clearly states that the device is for "total hip replacement" due to various conditions affecting the hip joint. This is a surgical procedure, not a diagnostic test performed on a sample.
The device described is a surgical implant used in orthopedic surgery, not an IVD.
N/A
Intended Use / Indications for Use
The M2a Magnum™ 12/14 Taper Inserts and One-Piece Modular Heads are intended for use in patients requiring total hip replacement due to the following:
-
- Non-inflammatory degenerative joint disease including avascular necrosis, diastrophic variant, fracture of the pelvis, fused hip, Legg Perthes, osteoarthritis, slipped capital epiphysis, subcapital fractures and traumatic arthritis.
-
- Rheumatoid arthritis.
-
- Correction of functional deformity.
-
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
-
- Revision of previously failed total hip arthroplasty.
Product codes
K.WA
Device Description
The M2a Magnum™ 12/14 Taper Inserts and One-Piece Modular Heads are designed for use with the Taper oc 12/14 taper femoral components and the articulating heads and shells of the M2a Maqnum™ Sytem (K043537) for uncemented applications.
There are two sets of taper inserts, each providing neck offsets from to +9mm. The first set has a smaller diameter and mates with modular head sizes 42mm. The second set of taper inserts has a larger outer diameter and mates with modular head sizes 52mm through 60mm. The one-piece 12/14 modular head sizes will include 38mm and 40mm outer diameters. Available neck offsets will range from -6mm to +9mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
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
Non-Clinical Testing: Non-clinical laboratory testing had been previously performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
K061423 (Pg 1 of 2)
Image /page/0/Picture/1 description: The image shows the logo for Biomet Orthopedics Inc. The logo consists of the word "BIOMET" in a bold, sans-serif font, with the letters connected to form a single block. Below the word "BIOMET" is the phrase "ORTHOPEDICS INC." in a smaller, serif font. The logo is simple and modern, and it is likely used to represent the company's brand.
JUL 27 2006
510(k) Summarv
Preparation Date: May 19, 2006
Applicant/Sponsor: Biomet Manufacturing Corp.
Contact Person: Becky Earl, Regulatory Specialist
Proprietary Name: M2a Magnum™ 12/14 Taper Inserts and One-Piece Modular Heads
Common Name: metal-on-metal inserts and modular heads
Classification Name: Hip joint metal/metal semi-constrained, with uncemented acetabular component prosthesis (888.3330)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: M2a Magnum™ Systems-K042037 (Biomet, Inc.); ASR™ Modular Acetabular Cup System-K040627 (DePuy Orthopaedics, Inc.), and TaperLoc® 12/14 Taper Femoral Components-K043537 (Biomet, Inc.).
Device Description: The M2a Magnum™ 12/14 Taper Inserts and One-Piece Modular Heads are designed for use with the Taper oc 12/14 taper femoral components and the articulating heads and shells of the M2a Maqnum™ Sytem (K043537) for uncemented applications.
There are two sets of taper inserts, each providing neck offsets from to +9mm. The first set has a smaller diameter and mates with modular head sizes 42mm. The second set of taper inserts has a larger outer diameter and mates with modular head sizes 52mm through 60mm. The one-piece 12/14 modular head sizes will include 38mm and 40mm outer diameters. Available neck offsets will range from -6mm to +9mm.
Intended Use:
The M2a Magnum™ 12/14 Taper Inserts and One-Piece Modular Heads are intended for use in patients requiring total hip replacement due to the following:
-
- Non-inflammatory degenerative joint disease including avascular necrosis, diastrophic variant, fracture of the pelvis, fused hip, Legg Perthes, osteoarthritis, slipped capital epiphysis, subcapital fractures and traumatic arthritis.
-
- Rheumatoid arthritis.
-
- Correction of functional deformity.
-
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
-
- Revision of previously failed total hip arthroplasty.
Summary of Technologies: The technological characteristics (materials, design, sizing, articulating surface, indications) of the M2a Magnum™ 12/14 Taper Inserts and One-Piece Modular Heads are similar or identical to the predicate devices.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
SHIPPING ADDRESS 56 E Boll Drive Warsaw, IN 46582
OFFICE 574.267.6639
FAX
574.267.8137
E-MAIL biomet@biomet.com
1
K061423 (pg 2 of 2)
Page 2 of 2 r uge = = = = Biomet Manufacturing Corp.
Non-Clinical Testing: Non-clinical laboratory testing had been previously performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are property of Biomet, Inc. except for ASR™ Modular Acetabular Cup System (DePuy Orthopaedics, Inc.)
2
Image /page/2/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized graphic in the center. The text around the perimeter appears to be the name of an organization or agency. The central graphic consists of three curved lines that resemble a bird in flight or a stylized representation of human figures. The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 7 2006
Biomet Manufacturing Corp. % Ms. Becky Earl Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K061423
Trade/Device Name: M2a Magnum™ 12/14 Taper Inserts and One--Piece Modular Heads Regulation Number: 21 CFR 888.3330
Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component prosthesis
Regulatory Class: Class III Product Code: K.WA Dated: May 22, 2006 Received: May 23, 2006
Dear Ms. Earl:
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
3
Page 2 - Ms. Becky Earl
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Hubertus
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): YOG1423
Device Name: M2a Magnum™ 12/14 Taper Inserts and One-Piece Modular Heads
Indications For Use:
The M2a Magnum™ 12/14 Taper Inserts and One-Piece Modular Heads are indicated for use in patients requiring total hip replacement due to the following:
-
- Non-inflammatory degenerative joint disease including avascular necrosis, diastrophic variant, fracture of the pelvis, fused hip, Legg Perthes, osteoarthritis, slipped capital epiphysis, subcapital fractures and traumatic arthritis.
-
- Rheumatoid arthritis.
-
- Correction of functional deformity.
-
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanaqeable by other techniques.
-
- Revision of previously failed total hip arthroplasty.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NO (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)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K061423