(24 days)
- Noninflammatory 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.
- Dislocation risks.
The ArComXL™ Active Articulation Head is a single-use implant, intended for uncemented applications.
The ArComXL™ Active Articulation belongs to the family of dual mobility acetabular implants: the presence of two articulating surfaces in the same joint device. The ArComXL™ Active Articulation Head fits over a femoral modular head, which articulates within the ArComXL™ Head. The resultant assembly then articulates within the acetabular metal shell. The ArComXL™ Head is designed to be used with several styles of acetabular shells that have been cleared in previous submissions: M²a Magnum™ (K042037), Magnum™ Tri-Spike (K062995), and M²a 38™ Flared Cups and Non-Flared Cups (K011110).
The ArComXL™ Active Articulation Heads are available in sizes 44-66mm (Note: Size 44-66mm references O.D. of mating shell; the actual head sizes are 38-60mm.) and are manufactured from highly cross-linked polyethylene, conforming to ASTM F648. ArComXL™ is not a new material; the material and manufacturing process were cleared in K042051, ArComXL™ Polyethylene Liners, as well as subsequent submissions. The ArComXL™ Active Articulation is designed for both primary and total revision surgeries, where all device components associated with the wear couple are removed and replaced. The system is intended for uncemented applications.
This document describes the Biomet ArComXL™ Active Articulation Head, a hip replacement component. This submission is for a material change from the predicate device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Push-In and Lever-Out | Equivalence to the Bipolar/Tri-Polar predicate (K991990). Meets or exceeds parameters. | Six samples demonstrated equivalence to the Bipolar/Tri-Polar predicate (K991990). Meets parameters. |
| Wear Testing | Wear rates less than that of the ArCom™ 36mm liners (K032396). Meets or exceeds parameters. | Tested for 5 million cycles, demonstrated equivalence to K032396. Meets parameters. |
2. Sample Size and Data Provenance
- Test Set Sample Size:
- Push-In and Lever-Out: Six samples.
- Wear Testing: Not explicitly stated, but typically multiple samples are used in ISO 14242 testing. The document states "the ArComXL™ Active Articulation heads were tested".
- Data Provenance: Not explicitly stated, but assumed to be from laboratory testing conducted by Biomet Manufacturing Corp. (the submitter). These are non-clinical tests.
3. Number of Experts and Qualifications for Ground Truth of Test Set
Not applicable. The reported studies are non-clinical mechanical tests (Push-In and Lever-Out, Wear Testing), not clinical studies requiring expert ground truth for interpretation.
4. Adjudication Method for Test Set
Not applicable. This section relates to clinical studies and expert review, which were not performed for the determination of substantial equivalence for this device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. No clinical studies were conducted, and therefore, no MRMC studies comparing human readers with and without AI assistance were performed. The device is a medical implant, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a physical implant, not an algorithm or software. The performance studies are non-clinical hardware tests.
7. Type of Ground Truth Used
- Push-In and Lever-Out: Comparison to the performance of a legally marketed predicate device (K991990), establishing functional equivalence.
- Wear Testing: Comparison to the wear rates of a legally marketed predicate device, ArCom™ 36mm liners (K032396), as per ISO 14242 standards.
8. Sample Size for Training Set
Not applicable. This device is a physical implant; there is no "training set" in the context of an algorithm or AI model development.
9. How Ground Truth for Training Set Was Established
Not applicable, as there is no training set for this device.
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i10555
MAR 2 4 2011
Image /page/0/Figure/2 description: The image shows the logo for Biomet Manufacturing Corp. The word "BIOMET" is displayed in a stylized, outlined font above the words "MANUFACTURING CORP." The logo is simple and professional, likely used for branding purposes.
510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92
| Submitter Information | |||
|---|---|---|---|
| Name | Biomet Manufacturing Corp. | ||
| Address | 56 East Bell DriveWarsaw, IN 46581-0857 | ||
| Phone number | (574) 267-6639 | ||
| Fax number | (574) 372-1683 | ||
| EstablishmentRegistration Number | 1825034 | ||
| Name of contactperson | Becky Earl | ||
| Date prepared | 02/23/2011 | ||
| Name of device | |||
| Trade or proprietaryname | ArComXL™ Active Articulation | ||
| Common or usualname | Artificial Hip Replacement Component--Acetabular | ||
| Classification name | Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis (21CFR §888.3358) | ||
| Classification panel | Orthopedic | ||
| Regulation | 21CFR §888.3358 | ||
| Product Code(s) | LPH (888.3358), LZO (888.3353), KWY (888.3390) | ||
| Legally marketeddevice(s) to whichequivalence is claimed | E1™ Avantage™ Head (E1™ Active Articulation), K101336 | ||
| Reason for 510(k)submission | The ArComXL™ Active Articulation is only a material changefrom the predicate, offering more options to patient,hospital, and surgeon. | ||
| Device description | The ArComXL™ Active Articulation belongs to the family ofdual mobility acetabular implants: the presence of twoarticulating surfaces in the same joint device. TheArComXL™ Active Articulation Head fits over a femoralmodular head, which articulates within the ArComXL™Head. The resultant assembly then articulates within theacetabular metal shell. The ArComXL™ Head is designed tobe used with several styles of acetabular shells that have | ||
| been cleared in previous submissions: M²a Magnum™ (K042037), Magnum™ Tri-Spike (K062995), and M²a 38™Flared Cups and Non-Flared Cups (K011110). | |||
| The ArComXL™ Active Articulation Heads are available insizes 44-66mm (Note: Size 44-66mm references O.D. ofmating shell; the actual head sizes are 38-60mm.) and aremanufactured from highly cross-linked polyethylene,conforming to ASTM F648. ArComXL™ is not a newmaterial; the material and manufacturing process werecleared in K042051, ArComXL™ Polyethylene Liners, as wellas subsequent submissions. The ArComXL™ ActiveArticulation is designed for both primary and total revisionsurgeries, where all device components associated with thewear couple are removed and replaced. The system isintended for uncemented applications. | |||
| Intended use of thedevice | The system is intended for uncemented applications. | ||
| Indications for use | 1. Noninflammatory degenerative joint disease, includingosteoarthritis and avascular necrosis.2. Rheumatoid arthritis.3. Correction of functional deformity.4. Treatment of non-union, femoral neck fracture andtrochanteric fractures of the proximal femur with headinvolvement, unmanageable using othertechniques.5. Revision of previously failed total hip arthroplasty.6. Dislocation risks.The ArComXL™ Active Articulation Head is a single-useimplant, intended for uncemented applications. | ||
| Summary of the technological characteristics of the device compared to thepredicate | |||
| Characteristic | New Device | Predicate | |
| Design | The ArComXL ActiveArticulation™ Head fits overa femoral modular head,which articulates within the | K101336 | |
| ArComXL™ head. Theresultant assembly thenarticulates within theacetabular metal shell. | K042051 | ||
| Material | ArComXL™, UHMWPE | ||
| Size Range | 44mm to 66mm | K101336 | |
| PERFORMANCE DATA | |||
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OFSUBSTANTIAL EQUIVALENCE | |||
| Performance Test Summary-New Device | |||
| Characteristic | Standard/Test/FDAGuidance | Results Summary | |
| Push-In and Lever-Out | NA | Six samples, identical to finalproduction product andtested in the same manneras the predicatedemonstrated equivalence tothe Bipolar/Tri-Polarpredicate. (K991990) | |
| Wear Testing | ISO 14242 | As in the E1™ ActiveArticulation predicate(K101336), the ArComXL™Active Articulation headswere tested for 5 millioncycles and compared to theArCom™ 36mm liners(K032396), the largest-sized,cleared ArCom™ liners.Acceptance criteria called forwear rates less than that ofthe ArCom liners; the testingdemonstrated equivalence toK032396. | |
| Comparative Performance Information Summary | |||
| Characteristic | Requirement | New Device | Predicate Device |
| Push-In and LeverOut | Meets or exceedsparameters | Meets parameters | K101336 |
| Wear Testing | Meets or exceedsparameters | Meets parameters | K101336 |
| Push-In and LeverOut | Meets or exceeds parameters | Meets parameters | K991990 |
| Wear Testing | Meets or exceeds parameters | Meets parameters | K032396 |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OFSUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION | |||
| Clinical Performance Data/Information: Not applicable |
P O. Box 567
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MANUFACTURING CORP.
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MANUFACTURING CORP.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
No clinical testing was necessary for a determination of substantial equivalence.
The results of mechanical testing indicated the devices performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices.
P O : Box 587
Warsow 1H 46Sa1-0507
Trail Fine: 8JX0 348.8500 011-01-27 17:57 1533 Main Fax: 574 267 8131
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
BioMet Manufacturing Corp. % Ms. Becky Earl Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-0587
Received: February 28, 2011
MAR 2 4 25.1
Re: K110555
Trade/Device Name: ArComXL" Active Articulation Head Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH, LZO, KWY Dated: February 25, 2011
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
{5}------------------------------------------------
Page 2 - Ms. Becky Earl
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 100, 1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, Jean note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 the number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
$\lg$ B. $R$ h
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): k1400555
Device Name: ArComXL™ Active Articulation Head
Indications For Use:
-
- Noninflammatory 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.
-
- Dislocation risks.
The ArComXL™ Active Articulation Head is a single-use implant, intended for uncemented applications.
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)
for M.Mellecam
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110555
Page 1 of 1
§ 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.