(85 days)
Not Found
No
The 510(k) summary describes a mechanical implant (femoral stem) and does not mention any software, algorithms, or data processing that would suggest the use of AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is a femoral hip prosthesis designed to replace the natural femoral hip component due to disease or accident, indicating its therapeutic purpose in restoring function and treating conditions like osteoarthritis and fractures.
No.
The device description indicates that the Parallel-Sided Extensively Coated Femoral Stem is designed to "replace the natural femoral hip component due to disease or accident," which is a treatment function, not a diagnostic one.
No
The device description clearly states it is a physical femoral hip prosthesis made from wrought titanium alloy, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device designed to replace a physical part of the body (the femoral hip component) due to disease or accident. This is a surgical implant, not a diagnostic test performed on samples from the body.
- Device Description: The description details the material and design of a physical prosthesis, not a reagent, instrument, or system used to examine specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information based on in vitro testing.
This device falls under the category of a surgical implant or prosthesis.
N/A
Intended Use / Indications for Use
-
- Non-Inflammatory 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 previous failed total hip arthroplasty.
The Parallel-Sided Extensively Coated Femoral Stems are for uncemented applications only.
Product codes (comma separated list FDA assigned to the subject device)
KWA, LPH, JDI, KWY, KWZ
Device Description
The Parallel-Sided Extensively Coated Femoral Stem is designed to replace the patural femoral hip component due to disease or accident. The femoral hip prosthesis is made from wrought titanium alloy (Ti-6AI-4V) (ASTM F136) and has a porous coat, designed to be used in uncemented applications. The stem diameters and lengths are within the range of the previously cleared predicates. In addition to the cylindrical stem design, the Parallel-Sided Extensively Coated Femoral Stem offers a lateralized offset for optimal patient fit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral hip component / 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)
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
K073637 page '92
MAR 2 0 2008
Image /page/0/Picture/2 description: The image shows the logo for Biomet Orthopedics, Inc. The logo is in black and white and features the word "BIOMET" in a stylized font with a superscripted "3". Below the word "BIOMET" is the text "ORTHOPEDICS, INC." in a smaller, sans-serif font. The logo is simple and professional, and it is likely used on the company's products, website, and marketing materials.
510(k) Summary
Parallel-Sided Extensively Coated Femoral Stem
Preparation Date: December 21, 2007
Biomet Manufacturing Corp. Applicant/Sponsor:
Elizabeth Wray Contact Person:
Parallel-Sided Extensively Coated Femoral Stem Proprietary Name:
- Hip ioint femoral replacement device Common Name:
Classification Name: - Class II, 21 CFR §888.3358, §888.3350, and §888.3353.
The mating components (modular heads and acetabular shells/liners) for use with the Parallel-Sided Extensively Coated Femoral Stem have the following classifications:
- Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/Polymer (888.3310) �
- Prosthesis, Hip, Semi-constrained, Metal/Polymer, Cemented (888.3350)
- Prosthesis, Hip, Semi-constrained, Metal/Ceramic/Polymer, Cemented or Non-porous, Uncemented (888.3353)
- Prosthesis, Hip, Semi-constrained, Metal/Polymer, Porous, Uncemented (888.3358) .
- Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented or Uncemented (888.3390)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
Reach® Revision System- K982367, 08/24/98 (Biomet Inc.) AML® Hip Stem- K012364, 10/19/01 (DePuy Inc.) XR-Series Bi-Metric® Femoral Stems- K052089, 02/17/06 (Biomet Inc.)
Device Description:
The Parallel-Sided Extensively Coated Femoral Stem is designed to replace the patural femoral hip component due to disease or accident. The femoral hip prosthesis is made from wrought titanium alloy (Ti-6AI-4V) (ASTM F136) and has a porous coat, designed to be used in uncemented applications. The stem diameters and lengths are within the range of the previously cleared predicates. In addition to the cylindrical stem design, the Parallel-Sided Extensively Coated Femoral Stem offers a lateralized offset for optimal patient fit.
P.O. Box 587
Warsaw IN 46581-0557
Toll Free: 800 348 9500
Office 574 767 6539
Main Fax 574 267.8137
www.biomet.com
1
Indications for Use/Intended Use:
-
- Non-Inflammatory 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 4. with head involvement, unmanageable by other techniques.
-
- Revision of previous failed total hip arthroplasty.
The Paraliel-Sided Extensively Coated Femoral Stems are for uncemented applications only.
Summary of Technologies:
The technological characteristics (materials, design, sizing, and indications) of the Parallel-Sided Extensively Coated Femoral Stem are similar or identical to the predicate devices or to other previously cleared devices.
Non-Clinical Testing:
Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are property of Biomet, Inc., except for AML®, which is a trademark of DePay, Inc.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight, composed of three curved lines.
MAR 2 0 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biomet Manufacturing Corp. c/o Ms. Elizabeth Wray Regulatory Affairs Specialist P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K073637 Trade/Device Name: Parallel-Sided Extensively Coated Femoral Stems Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: Class III Product Code: KWA, LPH, JDI, KWY, KWZ Dated: December 21, 2007 Received: December 26, 2007
Dear Ms. Wray:
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. Elizabeth Wray
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Mulhausen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of
Indications for Use
510(k) Number (if known): __ Koフふん3 7
Device Name:
Indications for Use:
-
- Non-Inflammatory 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 previous failed total hip arthroplasty.
The Parallel-Sided Extensively Coated Femoral Stems are for uncemented applications only.
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)
Souther
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K073637
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