(97 days)
No
The summary describes a physical medical device (acetabular liners) and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device, an acetabular liner for total hip arthroplasty, is used to treat various joint diseases and fractures, correcting functional deformities and revising failed arthroplasties, which constitutes therapy for these conditions.
No
The provided text describes a medical implant (acetabular liners) used for treatment and correction of hip joint conditions, not for diagnosing them.
No
The device description clearly states it is composed of physical materials (ArComXL™ polyethylene) and is an acetabular liner, which is a hardware component of a hip implant.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly describes a physical implant (acetabular liners) used in hip replacement surgery. Its intended use is to treat various conditions affecting the hip joint.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens from the patient. The device is directly implanted into the body.
Therefore, based on the provided information, the ArComXL™ Polyethylene Rx90™ Low Profile Acetabular Liners are a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ArComXL™ Polyethylene Rx90™ Low Profile Acetabular Liners are indicated for cemented or non-cemented use in cases of:
- Non-inflammatory degenerative joint disease including osteoarthritis and 1) avascular necrosis
- Rheumatoid arthritis 2)
- Correction of functional deformity 3)
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of 4) the proximal femur with head involvement, unmanageable by other techniques.
- Revision of previously failed total hip arthroplasty. 5)
Product codes
LPH, LZO, JDI, KWZ, MEH
Device Description
The new device is composed of ArComXL ™ with inner diameters of 28, 32, and 36mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, proximal femur
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 previously performed on the ArComXL ™ polyethylene predicate devices. Testing met or exceeded current standards or guidelines.
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
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
NOV 2 3 2005
510(k) Summary
Applicant/Sponsor:Biomet Manufacturing Corp. 56 East Bell Drive P.O. Box 587 Warsaw, IN 46581-0587
Contact Person: Allison K. Koskey Regulatory Specialist
Proprietary Name: ArComXL™ Polyethylene Rx90™ Low Profile Acetabular Liners
Common Name: Acetabular liner
Classification Name(s):
-
- Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis (21 CFR 888.3358)
-
- Hip joint metal/polymer semi-constrained cemented prosthesis (21 CFR 88.3350)
-
- Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (21 CFR 888.3353)
-
- Hip joint metal/polymer constrained cemented or uncemented prosthesis (21 CFR 888.3310)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Rx90™ Low Profile Acetabular System (K042989)
Device Description: The new device is composed of ArComXL ™ with inner diameters of 28, 32, and 36mm.
Intended Use: The ArComXL™ Polyethylene Rx90™ Low Profile Acetabular
Liners are indicated for single cemented or non-cemented use in cases of:
-
- 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 by other techniques
-
- Revision of previously failed total hip arthroplasty.
1
K052255 Pre
510(k) Summary Biomet, Inc. ArComXL ™ Polyethylene Rx90™ Low Profile Acetabular Liners Page 2 of 2
Summary of Technologies: The designs, intended use, contraindications, and design specifications of the subject components remain identical to their predicate counterparts. This submission allows the Rx90™ Low Profile Acetabular System to be composed of ArComXL™ with an inner diameter of 36mm.
Non-Clinical Testing: Verification activities were previously performed on the ArComXL ™ polyethylene predicate devices. Testing 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 and Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle is enclosed within a circular border. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is written around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 3 2005
Ms. Allison K. Koskey Regulatory Specialist Biomet Manufacturing Corp. 56 East Bell Drive P. O. Box 587 Warsaw, Indiana 46582
K052255 Re:
ArComXLIM Polyethylene Rx90™ Low Profile Acetabular Liners Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Codes: LPH, LZO, JDI, KWZ, MEH Dated: October 28, 2005 Received: October 31, 2005
Dear Ms. Koskey:
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. Allison K. Koskey
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/industry/support/index.html.
Sincerely yours,
signature
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
KOS 22 5 5 510(k) Number (if known): ___
Device Name: ArComXL™ Polyethylene Rx90™ Low Profile Acetabular Liners
Indications For Use: The ArComXL™ Polyethylene Rx90™ Low Profile Acetabular Liners are indicated for cemented or non-cemented use in cases of:
- Non-inflammatory degenerative joint disease including osteoarthritis and 1) avascular necrosis
- Rheumatoid arthritis 2)
- Correction of functional deformity 3)
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of 4) the proximal femur with head involvement, unmanageable by other techniques.
- Revision of previously failed total hip arthroplasty. 5)
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)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_KOS ZLLSS
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