(64 days)
No
The summary describes a hip stem implant made of standard materials with a porous coating. There is no mention of software, algorithms, image processing, AI, ML, or any data-driven components. The performance studies are non-clinical and focus on the physical functionality of the device.
Yes
The "Intended Use / Indications for Use" section lists various medical conditions such as osteoarthritis, avascular necrosis, rheumatoid arthritis, non-union of fractures, and revision of failed arthroplasty, and states the device is for the "Correction of functional deformity" and "Treatment of non-union." These are all therapeutic applications.
No
This device is a hip stem (implant) used for joint replacement and fracture treatment, not for diagnosing diseases or conditions.
No
The device description explicitly states the device is a hip stem made from Ti-6Al-4V and coated with Porous Plasma Spray, indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to the surgical treatment of hip joint conditions (osteoarthritis, rheumatoid arthritis, fractures, revisions). These are clinical procedures performed directly on the patient.
- Device Description: The device is a hip stem, which is an implantable medical device used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
-
- Noninflammatory 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 using other techniques
-
- Revision of previously failed total hip arthroplasty.
The Echo™ Bi-Metric® Press-Fit Stems are intended for uncemented use only.
Product codes
LZO, KWA, KWZ, JDL, JDI, MAY, MEH, LPH, KWL, LWJ, KWY
Device Description
The Echo™ Bi-Metric® Press-Fit Stems are hip stems made from Ti-6Al-4V conforming to ASTM F-136. Portions of the devices are coated with Porous Plasma Spray conforming to ASTM F-1580.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip (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
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the devices were functional within their intended use.
Clinical Testing: Clinical testing was not required for the predicate devices. Therefore, this submission contains no clinical testing.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the word "BIOMET" in a bold, sans-serif font. The letters are all capitalized and have a geometric design. The letters are black and the background is white. The word appears to be a logo or brand name.
K070274 1 of 2
510(k) Summary
January 24, 2007 Preparation Date:
APR - 3 2007
Applicant/Sponsor: Biomet Manufacturing Corp.
Contact Person: Susan Alexander
Echo™ Bi-Metric® Press-Fit Stems Proprietary Name:
Common Name: Hip Stem
Classification Code(s)/Name(s):
LZO - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (21 CFR §888.3353)
KWA - Hip joint metal/metal semi-constrained, with an uncemented acetabular component. prosthesis (21 CFR 6888.3330)
KWZ - Hip joint metal/polymer constrained cemented or uncemented prosthesis (21 CFR 888.3310)
JDL - Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis (21 CFR §888.3320)
JDI - Hip joint metal/polymer semi-constrained cemented prosthesis (21 CFR 6888,3350) MAY - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (21 CFR §888.3353)
MEH - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (21 CFR §888.3353)
LPH - Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis (21 CFR 6888.3358)
KWL - Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis (21 CFR 8888.3360)
LWJ - Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis (21 CFR $888.3360)
KWY -- Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis (21 CFR 6888.3390)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
Altra Press-Fit Hip Stem K063002 Biomet Manufacturing Corp.
Device Description: The Echo™ Bi-Metric® Press-Fit Stems are hip stems made from Ti-6Al-4V conforming to ASTM F-136. Portions of the devices are coated with Porous Plasma Spray conforming to ASTM F-1580.
Image /page/0/Figure/23 description: The image shows contact information for a company, including mailing address, shipping address, office phone number, fax number, and email address. The mailing address is P.O. Box 587, Warsaw, IN 46581 0587. The shipping address is 56 E. Bell Drive, Warsaw, IN 46582. The office phone number is 574.267.6639, the fax number is 574.267.8137, and the email address is biomet@biomet.com.
1
Indications for Use:
-
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis 2.
-
- Correction of functional deformity
-
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
-
- Revision of previously failed total hip arthroplasty.
The Echo™ Bi-Metric® Press-Fit Stems are intended for uncemented use only.
Summary of Technologies: The Echo™ Bi-Metric® Press-Fit Stems incorporate a similar design with similar technological features as the predicate hip stems. They have the same intended use, indications for use, and utilize the same Biomet Type I Taper as the predicate stems. These similarities demonstrate that the Echo™ Bi-Metric® Press-Fit Stems are substantially equivalent to the predicate hip stems.
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the devices were functional within their intended use.
Clinical Testing: Clinical testing was not required for the predicate devices. Therefore, this submission contains no clinical testing.
All trademarks are property of Biomet, Inc.
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 eagle or bird symbol, with three overlapping shapes suggesting wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biomet Manufacturing Corp. % Ms. Susan Alexander Regulatory Specialist Post Office Box 587 Warsaw, Indiana 46581
Re: K070274
Trade/Device Name: Echo™ Bi-Metric® Press Fit Stems Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with uncemented acetabular component, prosthesis Regulatory Class: III
APR - 3 2007
Product Code: KWA Dated: March 14, 2007 Received: March 15, 2007
Dear Ms. Alexander:
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
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 (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 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,
Tarbay Buehno
for
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _
Device Name: Echo™ Bi-Metric® Press Fit Stems
Indications For Use:
-
- Noninflammatory 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 using other techniques
-
- Revision of previously failed total hip arthroplasty.
The Echo™ Bi-Metric® Press-Fit Stems are intended for uncemented use only.
Prescription Use YES (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)
Barbara Buchm
Division of General, Restorative. and Neurological Devices
510(k) Number K070274
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