(108 days)
No
The 510(k) summary describes a mechanical orthopedic implant (hip stem) and its components. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is a modular calcar stem system intended for non-cemented application in hip replacement surgeries, which is a therapeutic intervention for various conditions such as revision, trauma, fracture, and oncology.
No
Explanation: The device is a hip implant (Mallory-Head® Modular Calcar Stems) used for non-cemented application in revision or trauma cases. It is a prosthetic device for repair and replacement, not for diagnosing conditions.
No
The device description clearly states it is a system of physical components (proximal metaphyseal segments, distal stems, cross-screws) intended for surgical implantation, which are hardware, not software.
No, 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, tissue) to provide information about a person's health.
- Device Description: The provided text describes a surgical implant – a hip stem used in hip replacement surgery. It is designed to be placed inside the body to provide structural support and stability.
- Intended Use: The intended use clearly states it's for "non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard type hip replacement prosthesis." This is a description of a surgical procedure and the device's role within that procedure.
The device is a Class II medical device (based on the 510(k) submission and predicate devices), but it falls under the category of orthopedic implants, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Mallory-Head® Modular Calcar Stems with Interlocking Slots are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard type hip replacement prosthesis.
Product codes
KWZ, JDL, KWA, JDI, LZO, LPH, KWY
Device Description
The Mailory-Head® Modular Calcar System consists of a variety of proximal metaphyseal segments and distal stems. This 510(k) was for a distal stem that has three medial/lateral slots located in the distal half of the device designed for cross screw placement. The proximal bodies and distal stems of the Mallory-Head® Modular Calcar System are joined by means of a Morse looking taper similar to that used to attach the modular head components to most hip stems. The cross-screws are available in lengths of 25mm to 60mm and 5mm diameters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
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: Mechanical testing has been conducted to demonstrate the ability of the screws to survive physiological loading.
Clinical Testing: None provided
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
K042774 JAN 2 1 2005
510(k) Summarv
Applicant/Sponsor: Biomet Manufacturing Corp.
Contact Person: Patricia Sandborn Beres Senior Regulatory Specialist
Proprietary Name: Mallory-Head® Modular Calcar Stems with Interlocking Siots
Common Name: Common or Usual Name: Total hip femoral component
Classification Name:
-
- Hip joint metal/polymer constrained cemented or uncemented prosthesis (21 CFR 888.3310)
-
- Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis (21 CFR 888.3320)
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- Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis (21 CFR 888.3330)
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- Hip joint metal/polymer semi-constrained cemented prosthesis (21 CFR 888.3350)
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- Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (21 CFR 888.3353)
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- Hip joint metal/polmer/metal semi-constrained, porous-coated, uncemented prosthesis (21 C.F.R. 888.3358)
- 7 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis (21 CFR 888.3390)
Product Codes: KWZ, JDL, KWA, JDI, LZO, LPH, KWY
Legally Markated Devices To Which Substantial Equivalence Is Claimed: Interlocking Hip Stems - K990830 Mallory-Head® Modular Calcar with and without HA - K031693
Device Description: The Mailory-Head® Modular Calcar System consists of a variety of proximal metaphyseal segments and distal stems. This 510(k) was for a distal stem that has three medial/lateral slots located in the distal half of the device designed for cross screw placement. The proximal bodies and distal stems of the
| MAILING ADDRESS | P.O. Box 587
Warsaw, IN 46581-0587 |
|------------------|---------------------------------------|
| SHIPPING ADDRESS | 56 E. Bell Drive
Warsaw, IN 46582 |
| OFFICE | 574.267.6639 |
| FAX | 574.267.8137 |
| E-MAIL | biomet@biomet.com |
1
510(k) Summary Mallory-Head® Modular Distal Stems with Interlocking Slots Page 2
Mallory-Head® Modular Calcar System are joined by means of a Morse looking taper similar to that used to attach the modular head components to most hip stems. The cross-screws are available in lengths of 25mm to 60mm and 5mm diameters.
Intended Use; Mallory-Head Modular Calcar Stems with Interfocking Slots are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard type hip replacement prosthesis.
Summary of Technologies: The Mallory-Head® Modular Distal Stems with Interlocking Slots have similar characteristics to the predicate devices.
Non-Clinical Testing: Mechanical testing has been conducted to demonstrate the ability of the screws to survive physiological loading.
Clinical Testing: None provided
ﺗ
All trademarks are property of Biomet, Inc.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an eagle-like emblem with three stylized lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
JAN 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Manufacturing Corp. P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K042774
Trade/Device Name: Mallory-Head® Modular Calcar Stems with Interlocking Slots Regulation Number: 21 CFR 888.3320; 21CFR 888.3330; 21 CFR 888.3358; 21 CFR 888.3353; 21 CFR 888.3310; 21 CFR 888.3350; 21 CFR 888.3390 Regulation Name: Hip joint metal/metal semi-constrained, with a cemented acetabular Component, prosthesis; Hip joint metal/metal semi-constrained with an uncemented acetabular component, prosthesis Hip joint metal/ polymer/ metal semi-constrained porous-coated uncemented prosthesis; Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prothesis; Hip joint metal/polymer constrained cemented or uncemented prosthesis; Hip joint metal / polymer semi-constrained cemented prosthesis; Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis; Regulatory Class: III Product Code: JDL, KWA, LPH, LZO, KWZ, JDI, and KWY
Dated: December 17, 2004 Received: December 20, 2004
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 10 mmerce 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.
3
Page 2 - Ms. Patricia Sandborn Beres
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (360 additional controls. Existing major regulations affecting your device it may be subject to saon additions, Title 21, Parts 800 to 898. In addition, FDA can oc lound in the Oous of concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that I Dr o lessan. Is a your device complies with other requirements of the Act that I DA has made a acterimistered by other Federal agencies. You must or any I caeful statuted and registments, including, but not limited to: registration and listing (21 Comply will an the Hot 870 cm mans) ; good manufacturing practice requirements as set CTN in the quality systems (21 CFR Part 820); and if applicable, the electronic forth in the quant) by some (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) I mis letter will anow you to organization of substantial equivalence of your device to a legally promatics notification: "The 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 if you desire 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 Snaall other general mionnal 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 vours.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K042774 510(k) Number (if known):
Device Name: Mallory-Head® Modular Calcar Stems with Interlocking Slots
Indications For Usc:
Mallory-Head® Modular Calcar Stems with Interlocking Slots are indicated for noncemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard type hip replacement prosthesis.
X Prescription Use __ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINIJE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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| 510(k) Number | K042774 |