(24 days)
No
The summary describes a mechanical implant (hip joint component) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is an implantable component for total hip arthroplasty, intended to treat various degenerative joint diseases and correct functional deformities. These are therapeutic interventions aimed at alleviating symptoms and restoring function.
No
The device is an implantable prosthetic head for a hip joint, intended for surgical treatment of various conditions and revision of failed surgeries. It performs a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a physical implant (ArComXL™ Active Articulation Head) made of highly cross-linked polyethylene, intended for surgical implantation in the hip joint. It is a hardware device, not software.
Based on the provided text, 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, or tissue) to provide information about a person's health.
- Device Description: The description clearly states that the ArComXL™ Active Articulation Head is a single-use implant designed to be part of a total hip arthroplasty. It is a physical component inserted into the body to replace a damaged hip joint.
- Intended Use: The intended uses listed are all related to the surgical treatment of hip joint conditions and the revision of previous hip surgeries. These are clinical procedures, not laboratory tests on samples.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information based on sample analysis.
- Reagents, calibrators, or controls.
- Laboratory procedures.
Therefore, the ArComXL™ Active Articulation Head is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
- Dislocation risks.
Product codes
LPH, LZO, KWY
Device Description
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Test Summary-New Device
- Push-In and Lever-Out:
- Standard/Test/FDA Guidance: NA
- Results Summary: Six samples, identical to final production product and tested in the same manner as the predicate demonstrated equivalence to the Bipolar/Tri-Polar predicate. (K991990)
- Wear Testing:
- Standard/Test/FDA Guidance: ISO 14242
- Results Summary: As in the E1™ Active Articulation predicate (K101336), the ArComXL™ Active Articulation heads were tested for 5 million cycles and compared to the ArCom™ 36mm liners (K032396), the largest-sized, cleared ArCom™ liners. Acceptance criteria called for wear rates less than that of the ArCom liners; the testing demonstrated equivalence to K032396.
Comparative Performance Information Summary
- Push-In and Lever Out (New Device vs. Predicate K101336):
- Requirement: Meets or exceeds parameters
- New Device: Meets parameters
- Predicate Device: K101336
- Wear Testing (New Device vs. Predicate K101336):
- Requirement: Meets or exceeds parameters
- New Device: Meets parameters
- Predicate Device: K101336
- Push-In and Lever Out (New Device vs. Predicate K991990):
- Requirement: Meets or exceeds parameters
- New Device: Meets parameters
- Predicate Device: K991990
- Wear Testing (New Device vs. Predicate K032396):
- Requirement: Meets or exceeds parameters
- New Device: Meets parameters
- Predicate Device: K032396
Summary of Clinical Tests Conducted:
Clinical Performance Data/Information: Not applicable. No clinical testing was necessary for a determination of substantial equivalence.
Conclusions:
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K042037, K062995, K011110, K042051, K991990, K032396
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
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 Drive | ||
| Warsaw, IN 46581-0857 | |||
| Phone number | (574) 267-6639 | ||
| Fax number | (574) 372-1683 | ||
| Establishment | |||
| Registration Number | 1825034 | ||
| Name of contact | |||
| person | Becky Earl | ||
| Date prepared | 02/23/2011 | ||
| Name of device | |||
| Trade or proprietary | |||
| name | ArComXL™ Active Articulation | ||
| Common or usual | |||
| name | 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 marketed | |||
| device(s) to which | |||
| equivalence is claimed | E1™ Avantage™ Head (E1™ Active Articulation), K101336 | ||
| Reason for 510(k) | |||
| submission | The ArComXL™ Active Articulation is only a material change | ||
| from the predicate, offering more options to patient, | |||
| hospital, and surgeon. | |||
| Device description | 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. | |||
| Intended use of the | |||
| device | The system is intended for uncemented applications. | ||
| Indications for use | 1. 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. | | |
| Summary of the technological characteristics of the device compared to the
predicate | | | |
| Characteristic | New Device | Predicate | |
| Design | The ArComXL Active
Articulation™ Head fits over
a femoral modular head,
which articulates within the | K101336 | |
| ArComXL™ head. The
resultant assembly then
articulates within the
acetabular metal shell. | | K042051 | |
| Material | ArComXL™, UHMWPE | | |
| Size Range | 44mm to 66mm | K101336 | |
| PERFORMANCE DATA | | | |
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF
SUBSTANTIAL EQUIVALENCE | | | |
| Performance Test Summary-New Device | | | |
| Characteristic | Standard/Test/FDA
Guidance | Results Summary | |
| Push-In and Lever-Out | NA | Six samples, identical to final
production product and
tested in the same manner
as the predicate
demonstrated equivalence to
the Bipolar/Tri-Polar
predicate. (K991990) | |
| Wear Testing | ISO 14242 | As in the E1™ Active
Articulation predicate
(K101336), the ArComXL™
Active Articulation heads
were tested for 5 million
cycles and compared to the
ArCom™ 36mm liners
(K032396), the largest-sized,
cleared ArCom™ liners.
Acceptance criteria called for
wear rates less than that of
the ArCom liners; the testing
demonstrated equivalence to
K032396. | |
| Comparative Performance Information Summary | | | |
| Characteristic | Requirement | New Device | Predicate Device |
| Push-In and Lever
Out | Meets or exceeds
parameters | Meets parameters | K101336 |
| Wear Testing | Meets or exceeds
parameters | Meets parameters | K101336 |
| Push-In and Lever
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
SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION | | | |
| Clinical Performance Data/Information: Not applicable | | | |
P O. Box 567
Wastaw. III 46581-0581
Tot Froe: 201348.9500 ிங்கு 574 267 6639 Ыза Fac 574 767 8137 anter hightel com
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ਹੈ। ਉ ਤੀ The Trans MANUFACTURING CORP.
ડ્રો
PO Box 087
Walker (103) Roma (103) Rosenti (108) Rosental (108) Rosental (100 Friday (100 Friday (100 Friday) Norther (1972) North (1972) National (1988) Nationa
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Image /page/2/Picture/0 description: The image shows a sequence of handwritten characters. The sequence appears to be "K110555". The characters are written in a simple, slightly irregular style, typical of handwriting. The image has a clear, white background, which makes the characters stand out.
Image /page/2/Picture/1 description: The image shows the word "BIOMET" in a stylized, outlined font. The letters are blocky and have a three-dimensional appearance due to the outlining. There is a small trademark symbol in the upper right corner of the image.
MANUFACTURING CORP.
P.O. Box 537
Wall Friday (2010-05-2010
Tuall Friday (2010-05-2010)
Tuall Friday (2012-02-2010)
Luxuri (2012-02-2010)
Kustif (2010) (2010) 10:137
World Donel Donn
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Image /page/3/Picture/1 description: The image shows the word "BIOMET" in a stylized, outlined font. The letters are blocky and have a three-dimensional appearance due to the outlining. The word is presented in all capital letters and appears to be a logo or brand name.
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
4
Image /page/4/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized bird in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The bird in the center is abstract, with flowing lines suggesting wings and a body.
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
6
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
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