ARCOMXL ACTIVE ARTICULATION

K110555 · Biomet Manufacturing Corp · LPH · Mar 24, 2011 · Orthopedic

Device Facts

• Record ID: K110555
• Device Name: ARCOMXL ACTIVE ARTICULATION
• Applicant: Biomet Manufacturing Corp
• Product Code: LPH · Orthopedic
• Decision Date: Mar 24, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The system is intended for uncemented applications.

Device Story

ArComXL™ Active Articulation Head is a dual-mobility acetabular implant component. It fits over a femoral modular head, creating an articulating surface that then articulates within an acetabular metal shell. Used in primary and total revision hip arthroplasty surgeries. Operated by orthopedic surgeons in a clinical/hospital setting. The device provides an additional articulating surface to improve joint stability and reduce dislocation risk. It is manufactured from highly cross-linked polyethylene (UHMWPE).

Clinical Evidence

No clinical data was provided. Substantial equivalence was determined based on bench testing, including push-in/lever-out mechanical testing and wear testing per ISO 14242 for 5 million cycles, which demonstrated equivalence to predicate devices.

Technological Characteristics

Dual-mobility acetabular implant. Material: Highly cross-linked ultra-high-molecular-weight polyethylene (UHMWPE) conforming to ASTM F648. Sizes: 44-66mm (O.D. of mating shell). Application: Uncemented. Design: Articulating head fits over femoral modular head, which then articulates within an acetabular metal shell.

Indications for Use

Indicated for patients with noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, non-union, femoral neck/trochanteric fractures of the proximal femur with head involvement, or revision of failed total hip arthroplasty, and those at risk of dislocation. Single-use implant for uncemented applications.

Regulatory Classification

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.

Predicate Devices

• E1™ Avantage™ Head (E1™ Active Articulation) (K101336)

Reference Devices

• M²a Magnum™ (K042037)
• Magnum™ Tri-Spike (K062995)
• M²a 38™ Flared Cups and Non-Flared Cups (K011110)
• ArComXL™ Polyethylene Liners (K042051)
• Bipolar/Tri-Polar predicate (K991990)
• ArCom™ 36mm liners (K032396)

Submission Summary (Full Text)

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## MAR 2 4 2011

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## 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 Drive<br>Warsaw, IN 46581-0857 | | |
| Phone number | [phone] | | |
| Fax number | [phone] | | |
| Establishment<br>Registration Number | 1825034 | | |
| Name of contact<br>person | Becky Earl | | |
| Date prepared | 02/23/2011 | | |
| Name of device | | | |
| Trade or proprietary<br>name | ArComXL™ Active Articulation | | |
| Common or usual<br>name | Artificial Hip Replacement Component--Acetabular | | |
| Classification name | Hip joint metal/polymer/metal semi-constrained porous-<br>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 marketed<br>device(s) to which<br>equivalence is claimed | E1™ Avantage™ Head (E1™ Active Articulation), K101336 | | |
| Reason for 510(k)<br>submission | The ArComXL™ Active Articulation is only a material change<br>from the predicate, offering more options to patient,<br>hospital, and surgeon. | | |
| Device description | The ArComXL™ Active Articulation belongs to the family of<br>dual mobility acetabular implants: the presence of two<br>articulating surfaces in the same joint device. The<br>ArComXL™ Active Articulation Head fits over a femoral<br>modular head, which articulates within the ArComXL™<br>Head. The resultant assembly then articulates within the<br>acetabular metal shell. The ArComXL™ Head is designed to<br>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™<br>Flared Cups and Non-Flared Cups (K011110). | | | |
| The ArComXL™ Active Articulation Heads are available in<br>sizes 44-66mm (Note: Size 44-66mm references O.D. of<br>mating shell; the actual head sizes are 38-60mm.) and are<br>manufactured from highly cross-linked polyethylene,<br>conforming to ASTM F648. ArComXL™ is not a new<br>material; the material and manufacturing process were<br>cleared in K042051, ArComXL™ Polyethylene Liners, as well<br>as subsequent submissions. The ArComXL™ Active<br>Articulation is designed for both primary and total revision<br>surgeries, where all device components associated with the<br>wear couple are removed and replaced. The system is<br>intended for uncemented applications. | | | |
| Intended use of the<br>device | The system is intended for uncemented applications. | | |
| Indications for use | 1. Noninflammatory degenerative joint disease, including<br>osteoarthritis and avascular necrosis.<br>2. Rheumatoid arthritis.<br>3. Correction of functional deformity.<br>4. Treatment of non-union, femoral neck fracture and<br>trochanteric fractures of the proximal femur with head<br>involvement, unmanageable using other<br>techniques.<br>5. Revision of previously failed total hip arthroplasty.<br>6. Dislocation risks.<br>The ArComXL™ Active Articulation Head is a single-use<br>implant, intended for uncemented applications. | | |
| Summary of the technological characteristics of the device compared to the<br>predicate | | | |
| Characteristic | New Device | Predicate | |
| Design | The ArComXL Active<br>Articulation™ Head fits over<br>a femoral modular head,<br>which articulates within the | K101336 | |
| ArComXL™ head. The<br>resultant assembly then<br>articulates within the<br>acetabular metal shell. | | K042051 | |
| Material | ArComXL™, UHMWPE | | |
| Size Range | 44mm to 66mm | K101336 | |
| PERFORMANCE DATA | | | |
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF<br>SUBSTANTIAL EQUIVALENCE | | | |
| Performance Test Summary-New Device | | | |
| Characteristic | Standard/Test/FDA<br>Guidance | Results Summary | |
| Push-In and Lever-Out | NA | Six samples, identical to final<br>production product and<br>tested in the same manner<br>as the predicate<br>demonstrated equivalence to<br>the Bipolar/Tri-Polar<br>predicate. (K991990) | |
| Wear Testing | ISO 14242 | As in the E1™ Active<br>Articulation predicate<br>(K101336), the ArComXL™<br>Active Articulation heads<br>were tested for 5 million<br>cycles and compared to the<br>ArCom™ 36mm liners<br>(K032396), the largest-sized,<br>cleared ArCom™ liners.<br>Acceptance criteria called for<br>wear rates less than that of<br>the ArCom liners; the testing<br>demonstrated equivalence to<br>K032396. | |
| Comparative Performance Information Summary | | | |
| Characteristic | Requirement | New Device | Predicate Device |
| Push-In and Lever<br>Out | Meets or exceeds<br>parameters | Meets parameters | K101336 |
| Wear Testing | Meets or exceeds<br>parameters | Meets parameters | K101336 |
| Push-In and Lever<br>Out | Meets or exceeds parameters | Meets parameters | K991990 |
| Wear Testing | Meets or exceeds parameters | Meets parameters | K032396 |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF<br>SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION | | | |
| Clinical Performance Data/Information: Not applicable | | | |

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Wastaw. III 46581-0581
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PO Box 087
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MANUFACTURING CORP.

P.O. Box 537
Wall Friday (2010-05-2010
Tuall Friday (2010-05-2010)
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Luxuri (2012-02-2010)
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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: [phone]

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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

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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 [phone] or [phone] 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:

- 1. Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis.
- 2. Rheumatoid arthritis.
- 3. Correction of functional deformity.
- 4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- 5. Revision of previously failed total hip arthroplasty.
- 6. 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

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