(29 days)
No
The summary describes a mechanical implant (femoral stem) and does not mention any software, algorithms, or data processing capabilities that would suggest the use of AI/ML. The device description focuses on material and size changes compared to predicates.
Yes
It is a femoral stem used to treat various conditions of the joint, including degenerative joint disease, arthritis, and fractures. These are conditions that impair function and structure of the body, and its use is to restore previous health.
No
This device is a femoral stem used in joint replacement surgery, which is a treatment for various musculoskeletal conditions, not a tool for diagnosing them.
No
The device description explicitly states it is a femoral stem, which is a physical implant used in hip replacement surgery. This is a hardware device, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided information clearly describes a femoral stem, which is an implantable device used in hip replacement surgery. Its intended uses are related to treating conditions affecting the proximal femur and hip joint.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or provide diagnostic information. Its function is purely mechanical and structural within the body.
Therefore, based on the provided information, the HA Mallory/Head® Porous Femoral Stem & HA Mallory/Head® Porous Lateralized Femoral Stem are not In Vitro Diagnostic devices. They are surgical implants.
N/A
Intended Use / Indications for Use
The HA Mallory/Head® Porous Femoral Stems & HA Mallory/Head® Porous Lateralized Femoral Stems are for ) Non-inflammatory 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; and 5) Revision procedures where other treatments or devices have failed.
Product codes
MEH, LPH
Device Description
The HA Mallory/Head® Porous Femoral Stems & HA Mallory/Head® Porous Lateralized Femoral Stems are the same as each of their predicate(s)- Mallory/Head® Femoral Stem 510(k)- K921181 and Mallory/Head® Lateralized Press-Fit Femorals 510(k)s- K000538 and K003429, except for the addition of Hydroxyapatite Coating and additional sizes for the standard femoral stems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral, Hip Joint
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 with an Engineering Justification determined that the HA Mallory/Head® Porous Femoral Stems & HA Mallory/Head® Porous Lateralized Femoral Stems' components presented no new risks and were, therefore, substantially equivalent to the predicate device.
Clinical Testing: No clinical testing was provided as a basis for substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Mallory/Head® Porous Femoral Stem 510(k)- K921181, Mallory/Head® Lateralized Press-Fit Femorals 510(k)s- K000538, K003429
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
page 1 of 2
CORPORA RTERS
SUMMARY OF SAFETY AND EFFECTIVENESS
Applicant or Sponsor:
Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, IN 46581-0587
Contact Person:
Dalene T. Binkley Telephone: (574) 267-6639
Proprietary Name: HA Mallory/Head® Porous Femoral Stem & HA Mallory/Head® Porous Lateralized Femoral Stem
Common Name: Prosthetic Hip Joint – Hydroxyapatite (HA) Coated Porous Femoral Stem
Classification: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, nonporous, calcium-phosphate
Device Classification: Class II
Legally Marketed Device to which Substantially Equivalence is Claimed: Mallory/Head® Porous Femoral Stem 510(k)- K921181 and Mallory/Head® Lateralized Press-Fit Femorals 510(k)s- K000538 and K003429.
Device Description: The HA Mallory/Head® Porous Femoral Stems & HA Mallory/Head® Porous Lateralized Femoral Stems are the same as each of their predicate(s)- Mallory/Head® Femoral Stem 510(k)- K921181 and Mallory/Head® Lateralized Press-Fit Femorals 510(k)s- K000538 and K003429, except for the addition of Hydroxyapatite Coating and additional sizes for the standard femoral stems.
Indications for Use: The indications for the HA Mallory/Head® Porous Femoral Stems & HA Mallory/Head® Porous Lateralized Femoral Stems are for ) Non-inflammatory 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; and 5) Revision procedures where other treatments or devices have failed.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
프
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
.
00100
OFFICE 219.267.6639
FAX 219.267.8137
E-MAIL biomet@biomet.com
1
Page 2 of 2
001.09
Summary of Technologies: The HA Mallory/Head® Porous Femoral Stems & HA Mallory/Head® Porous Lateralized Femoral Stems' components-the materials, design, sizing, and indications are similar or identical to the predicate devices.
Non-Clinical Testing: Mechanical Testing with an Engineering Justification determined that the HA Mallory/Head® Porous Femoral Stems & HA Mallory/Head® Porous Lateralized Femoral Stems' components presented no new risks and were, therefore, substantially equivalent to the predicate device.
Clinical Testing: No clinical testing was provided as a basis for substantial equivalence.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 31 2002
Ms. Dalene T. Binkley Regulatory Affairs Specialist Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, IN 46581-0587
Re: K021403
Trade/Device Name: HA Mallory/Head® Porous Femoral Stem & HA Mallory/Head® Porous Lateralized Femoral Stem
Regulation Number: 21 CFR 888.3358
Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis
Regulatory Class: II Product Code: MEH, LPH Dated: April 26, 2002 Received: May 2, 2002
Dear Ms. Binkley:
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.
3
Page 2 – Ms. Dalene T. Binkley
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to obgin manisang your device of your device to a legally premaired 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 and II you desire specific acrited to: your avitro diagnostic devices), please contact the Office of additionally 21 CHC Fart 607.10 for his raily, for questions on the promotion and advertising of Compliance at (301) 291 1659 - 1550 - 155ce of Compliance at (301) 594-4639. Also, please note the your device, prease connecting by reference to premarket notification" (21CFR Part 807.97). It guiation entitued, "Nilostanang oresponsibilities under the Act may be obtained from the Outcl general information on your step 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,
R. Mark H. Millman
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
Page _ of _
510 (k) NUMBER (IF KNOWN): _ K O 21 4 v 3
DEVICE NAME: HA Mallory/Head® Porous Femoral Stem & HA Mallory/Head® Porous Lateralized Femoral Stem
INDICATIONS FOR USE:
The HA Mallory/Head® Porous Femoral Stem & HA Mallory/Head® Porous Lateralized Femoral Stem are indicated for use for 1) Non-inflammatory 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; and 5) Revision procedures where other treatments or devices have failed.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
KO21403
Over-The-Counter-Use $\underline{No}$
(Optional Format 1-2-96)
Mark n Milkesen
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_
00009