(67 days)
No
The summary describes a hip implant device and its components, focusing on material properties and size variations. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is an acetabular liner and femoral heads, intended for use in total hip arthroplasty to treat conditions like osteoarthritis and rheumatoid arthritis, which are therapeutic interventions.
No
The device description and intended use indicate it is an implantable medical device (hip arthroplasty components) used for treatment and correction of conditions, not for diagnosing them.
No
The device description clearly indicates it is a physical medical device (acetabular liners and femoral heads made of polyethylene and CoCrMo) and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses are all related to the surgical treatment of hip joint conditions (osteoarthritis, rheumatoid arthritis, fractures, revisions). These are clinical treatments performed directly on the patient.
- Device Description: The device is described as acetabular liners and femoral heads, which are components of a hip implant. These are physical devices implanted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside of the body to provide information about a patient's health status. IVDs are used for diagnosis, monitoring, or screening based on in vitro analysis.
This device is clearly a medical device intended for surgical implantation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis.
-
- Correction of functional deformity.
-
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
-
- Revision of previously failed total hip arthroplasty.
Cemented and Uncemented Applications
Product codes
LZO
Device Description
Biomet Manufacturing Corp. is adding additional sizes and designs to the predicate ArComXL™ Acetabular Liners (K042051). The same manufacturing process used in the predicate results in a higher cross-linked polyethylene that Biomet will herein refer to as ArComXL™ . The femoral heads, sizes 38mm and 40mm, are a one-piece design with neck length variations ranging from -6mm to +9mm made from CoCrMo.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip joint
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: Verification activities were performed on ArComXL™ liners, which met or exceeded current standards or guidelines.
Clinical Testing: None provided as a basis for substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
K042051, K023357, K032396, K011110, K042037
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
K062997 1/2
BIOMET
ORTHOPEDICS, INC.
510(k) Summar
| Preparation Date: | September 28, 2006 | |
|---|---|---|
| Applicant/Sponsor: | Biomet Manufacturing Corp. | |
| 56 East Bell Drive | ||
| P.O. Box 587 | ||
| Warsaw, IN 46581-0587 | DEC 08 2006 | |
| Contact Person: | Becky Earl | |
| Proprietary Name: | ArComXL™ Polyethylene Liners and 38/40mm Femoral Heads | |
| Common Name: | UHMWPE; Femoral Heads | |
| Classification Name: | - hip joint metal/polymer/metal semi-constrained porous coated | |
| uncemented prosthesis (888.3358) |
- hip joint metal/polymer semi-constrained cemented prosthesis
(888.3350) - hip joint metal/ceramic/polymer semi-constrained cemented or
nonporous uncemented prosthesis (888.3353) | |
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: ArComXL™ Acetabular Liners— K042051 (Biomet, Inc.), ArCom® Acetabular Liners—K023357 (Biomet, Inc.), 36mm MaxRom™ Acetabular Liners—K032396 (Biomet, Inc.), M2a™ Acetabular System—K011110 (Biomet, Inc.), and M2a Magnum™ System-K042037 (Biomet, Inc.)
Device Description: Biomet Manufacturing Corp. is adding additional sizes and designs to the predicate ArComXL™ Acetabular Liners (K042051). The same manufacturing process used in the predicate results in a higher cross-linked polyethylene that Biomet will herein refer to as ArComXL™ . The femoral heads, sizes 38mm and 40mm, are a one-piece design with neck length variations ranging from -6mm to +9mm made from CoCrMo.
Intended Use:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis.
-
- Correction of functional deformity.
-
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
-
- Revision of previously failed total hip arthroplasty.
Cemented and Uncemented Applications
Summary of Technologies: The intended use, indications, and design specifications of the acetabular liners remain similar or identical to their predicate component counterparts. The only exception is the addition of 32 and 36mm in two designs and 38 and 40mm size liners for all included designs. The raw material being utilized in the manufacture of the subject devices is an ultra-high
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
■
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
OFFICE 574.267.6639
FAX
574.257.8137
E-MAIL biomet@biomet.com
1
K062997 2/2
510(k) Summary - Page 2 of 2 STO(R) Summal y - Continuers and 38/40mm Femoral Heads (Continued)
molecular weight polyethylene (UHMWPE) per ASTM F-648, identical to the predicate (K042051). The morecallar welght polychylche (OHTTP: 2) per Rom P" (UHMWPE) Acetabular Liners were previously established in K042051.
The intended use, indications, contraindications, and design specifications of the femoral heads are The Interious use, Indications, contrainciedions, and acticulating surface which is changed from metal-onluentical to their predicates with the encopies in either cemented or uncemented applications.
Non-Clinical Testing: Verification activities were performed on ArComXL™ liners, which met or exceeded current standards or guidelines.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are property of Biomet, Inc.
2
Image /page/2/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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 8 2006
Biomet Manufacturing Corp. % Ms. Becky Earl Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K062997
Trade/Device Name: ArComXL™ Polyethylene Liners and 38/40mm Femoral Heads Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO Dated: September 29, 2006 Received: October 02, 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
3
Page 2 - Ms. Becky Earl
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Barbara Buchner
Mark N. Me. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
062997 ''//
Indications for Use
510(k) Number (if known):
Device Name: ArComXL™ Polyethylene Liners and 38/40mm Femoral Heads
Indications For Use:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis.
-
- Correction of functional deformity.
-
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
-
- Revision of previously failed total hip arthroplasty.
Cemented and Uncemented Applications
Prescription Use X (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)
Barbara Buchholz
Restorative,
510(k) Number
Page 1 of 1