(21 days)
Not Found
No
The summary describes a mechanical orthopedic implant (femoral stem) and its modifications (profile and coating). There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are mechanical testing, not algorithmic validation.
Yes
The device is a femoral stem used for treating various joint diseases, fractures, and deformities, which are all conditions that require therapeutic intervention.
No
The device is a femoral stem intended for reconstructive surgery to treat conditions like degenerative joint disease and fractures, not to diagnose them.
No
The device description clearly identifies the device as "Femoral Stems," which are physical implants, not software. The summary focuses on mechanical testing and material properties (Hydroxyapatite Coating), further indicating a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The indications clearly describe the device's use in surgical procedures for treating conditions affecting the proximal femur (hip joint). This is a therapeutic use, not a diagnostic one.
- Device Description: The description details a femoral stem, which is an implant used in hip replacement surgery. This is a medical device, not a diagnostic reagent or instrument used to examine specimens from the human body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition based on in vitro examination.
- Using reagents, calibrators, or controls.
The device is a surgical implant used to treat musculoskeletal conditions, which falls under the category of a medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The indications for the HA Modular Reach™ Proximal Porous and HA Modular Reach™ Collared Proximal Porous Femoral Stems are for ) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) Rheumatoid arthritis; 3) Correction of functional deformity; 4) Treatment of nonunion, 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
LPH
Device Description
The HA Modular Reach™ Proximal Porous and HA Modular Reach™ Collared Proximal Porous Femoral Stems are the same as their predicate, except for a modified profile on two of the sizes and the addition of Hydroxyapatite Coating.
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 Modular Reach™ Proximal Porous and HA Modular Reach™ Collared Proximal Porous Femoral Stems 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)
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
AUG 1 6 2002
K012463 pge 172
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 Modular Reach™ Proximal Porous and HA Modular Reach™ Collared Proximal Porous Femoral Stems
Common Name: Prosthetic Hip Joint - Hydroxyapatite (HA) Coated Porous Femoral Stem
Classification: hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis
Device Classification: Class II
Legally Marketed Device to which Substantial Equivalence is Claimed: Modular Reach™ Hip- 510(k) K994038.
Device Description: The HA Modular Reach™ Proximal Porous and HA Modular Reach™ Collared Proximal Porous Femoral Stems are the same as their predicate, except for a modified profile on two of the sizes and the addition of Hydroxyapatite Coating.
Indications for Use: The indications for the HA Modular Reach™ Proximal Porous and HA Modular Reach™ Collared Proximal Porous Femoral Stems are for ) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) Rheumatoid arthritis; 3) Correction of functional deformity; 4) Treatment of nonunion, 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.
Summary of Technologies: The HA Modular Reach™ Proximal Porous and HA Modular Reach™ Collared Proximal Porous Femoral Stems- the materials, design, sizing, and indications are similar or identical to the predicate devices.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587 - - - -
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
트
000046
()FFICE 574.267.6639 ■ ■ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
E-MAIL biomet@biome1.com
1
Non-Clinical Testing: Mechanical Testing with an Engineering Justification determined that the HA Modular Reach™ Proximal Porous and HA Modular Reach™ Collared Proximal Porous Femoral Stems 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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of a human figure in profile, with three overlapping heads suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 6 2002
Ms. Dalene T. Binkley Regulatory Affairs Specialist Biomet Orthopedics, Inc. P.O. box 587 Warsaw, Indiana 46581-0587
Re: K022463
Trade/Device Name: HA Modular Reach™ Proximal Porous and HA Modular Reach™ Collared Proximal Porous Femoral Stems Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: LPH Dated: July 15, 2002 Received: July 26, 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) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours.
Sincerely yours,
Mark A. 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 2 >46 -
DEVICE NAME: HA Modular Reach™ Proximal Porous and HA Modular Reach™ Collared Proximal Porous Femoral Stems
INDICATIONS FOR USE:
The indications for the HA Modular Reach™ Proximal Porous and HA Modular Reach™ Collared Proximal Porous 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.
(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
Over-The-Counter-Use No
(Optional Format 1-2-96)
Mark H. Millican
ivision Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K022463
0000008