(65 days)
Cemented and non-cemented total joint replacement in cases of:
- Noninflamatory 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
Each stem consists of two separate parts, a proximal metaphyseal segment and a distal stem. A variety of stem lengths and proximal segment sizes allow the surgeon to "construct" the proper sized implant while in surgery. All pieces are interchangeable. The device utilizes a modular femoral head taper fit on to the stem at the time of surgery. The proximal segment is designed to replace the proximal portion of the femur in cases of severe bone loss. The device is porous coated. The proximal components are available in 5 resection levels and 7 widths. A hole through the proximal component gives the surgeon the option of using a trochanter plate and trochanter bolt or a trochanter claw. This assembly will allow the greater trochanter to be compressed against the prosthesis for enhanced fixation and proximal stability. Distal stems are available in six lengths, 165mm, 200mm, 240mm, 250mm and 300mm. Stems are available with 40%, 80% or 100% of the stem porous coated, as well as a non-coated, splined configuration. Since the stems are modular, left and right components are not necessary. The proximal and distal segments are joined by means of a Morse locking taper similar to that used to attach the modular head components to most hip stems. Additional fixation is achieved through a locking screw inserted through the driving platform on the metaphyseal component and engaging with the stem taper.
The provided document is a 510(k) premarket notification for a medical device (Mallory-Head® Modular Calcar Femoral Component). It describes the device, its intended use, and claims substantial equivalence to previously marketed devices. However, it explicitly states:
- Clinical Testing: None provided.
Therefore, there is no information in this document regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details. This type of submission relies on demonstrating substantial equivalence to predicates through non-clinical testing (engineering analysis, finite element analysis, and mechanical testing) rather than new clinical data.
In summary, as per the provided document:
There is no information available regarding:
- A table of acceptance criteria and the reported device performance.
- Sample sizes used for a test set or data provenance.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication method.
- MRMC comparative effectiveness study or its effect size.
- Standalone performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
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AUG - 6 2003
Image /page/0/Picture/1 description: The image shows the logo for Biomet Orthopedics, Inc. The word "BIOMET" is in large, bold, block letters on the top line. The words "ORTHOPEDICS, INC" are in smaller letters on the second line, centered below the first word.
page 1 of 2
ORTHOPEDICS, INC.
Summary of Safety and Effectiveness
Applicarit/Sponsor:Biomet Orthopedics, Inc.
Contact Person: Patricia Sandborn Beres Senior Regulatory Specialist
Proprietary Name: Mallory-Head® Modular Calcar Femoral Component with and without HF
Cc mmon Name: Total hip femoral component
Classification Name: Hip joint metal/polymer/metal semi-constrained, porous coated, uncemented prosthesis (21 CFR 888.3358)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Miallory-Head Modular Calcar Replacement Components, 510(k) K945115 Mallory-Head Modular Calcar Total Hip with Roller- Hardened/Machined Tapers, 510(k) KU00335
Tr e Reach® Femoral Component, 510(k) K000760
Mallory-Head Modular Calcar (100% porous stems), 510(k) K001660 The HA Modular Reach® Femoral Component, 510(k) K022463
Device Description: : Each stem consists of two separate parts, a proximal metaphyseal segment and a distal stem. A variety of stem lengths and proximal segment sizes allow the surgeon to "construct" the proper sized implant while in surgery. All pieces are in erchangeable. The device utilizes a modular femoral head taper fit on to the stem at the time of surgery.
T re proximal segment is designed to replace the proximal portion of the femur in cases of suvere bone loss. The device is porous coated. The proximal components are available ir 5 resection levels and 7 widths.
A hole through the proximal component gives the surgeon the option of using a trochanter p ate and trochanter bolt or a trochanter claw. This assembly will allow the greater tr ochanter to be compressed against the prosthesis for enhanced fixation and proximal s :ability.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
1
SHIPPING ADDRESS Airport Industrial Park Warsaw, IN 46580
1
OFFICE 219.267.6639
I·AX 219.267.8137
E-MAIL וואסט.comet@biomet.con
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page 2 of 2
K031693
Dis al stems are available in six lengths, 165mm, 200mm, 240mm, 250mm and 30( mm. Stems are available with 40%, 80% or 100% of the stem porous coated, as well as a non-coated, splined configuration, Since the stems are modular, left and right cor ponents are not necessary.
Th‹› proximal and distal segments are joined by means of a Morse locking taper similar to tha: used to attach the modular head components to most hip stems. Additional fixation is ach ieved through a locking screw inserted through the driving platform on the metaphyseal cornponent and engaging with the stem taper.
Int anded Use: Non-cemented application in cases of:
- Noninflamatory degenerative joint disease including osteoarthritis and avascular 1) necrosis
-
- Fheumatoid arthritis
- Correction of functional deformity 3)
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the 4) proximal femur with head involvement, unmanageable by other techniques.
- Flevision of previously failed total hip arthroplasty 5)
Su mmary of Technologies: The materials, design and processing of the devices are identical to or similar to the predicates.
N‹››Clinical Testing: Engineering analysis, finite Element Analysis and mechanical te: ting were provided.
Clinical Testing: None provided .
All Tractemarks are property of Biomet, Inc.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/12 description: The image is a black and white seal. The seal is circular and contains text around the perimeter. The text reads "Department of Health & Human Services USA". In the center of the seal is a stylized symbol that resembles three abstract human profiles or faces.
AUG - 6 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, IN 46581-0587
Re: K031693
Trade/Device Name: Mallory-Head Modular Calcar with and without HA 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 Dated: July 18, 2003 Received: July 22, 2003
Dear Ms. Beres:
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 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.
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Page 2 - Ms. Patricia Sandborn Beres
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 (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510[k) Number (if known): K031693
Device Name: Mallory/Head Modular Calcar with and without HA
Indications For Use:
Cemented and non-cemented total joint replacement in cases of:
-
- Noninflamatory 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
iriam C. Provost
on of General. Restorative and Neurological Devices
510(k) Number K031693
(I'LEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
f 'rescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Formal 1-2-96)
§ 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.