(29 days)
Not Found
No
The summary describes a mechanical hip implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device, the Altra™ Press-Fit Hip System, is intended for the treatment of various medical conditions such as degenerative joint disease, rheumatoid arthritis, fractures, and revision of failed hip arthroplasty, which are all therapeutic interventions aimed at restoring health or alleviating symptoms.
No
The device is a hip implant system used for treatment of joint diseases and fractures, not for diagnosing them.
No
The device description explicitly states it is a "hip stem made from Ti-6AJ-4V titanium alloy," which is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed 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 description clearly states that the Altra™ Press-Fit Hip System is a hip stem made from titanium alloy and is intended for surgical implantation to treat various hip conditions like osteoarthritis, rheumatoid arthritis, fractures, and revision of failed hip replacements. This is a surgically implanted medical device, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for 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 Altra™ Press-Fit Hip System is intended for uncemented use only.
Product codes (comma separated list FDA assigned to the subject device)
KWA, JDL, LZO, KWZ, JDI, MAY, MEH, LPH, KWL, LWJ, KWY
Device Description
The Altra™ Press-Fit Hip System consists of a hip stem made from Ti-6AJ-4V titanium alloy conforming to ASTM F-136.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing demonstrated that the Altra™ Press-Fit Hip System is substantially equivalent to the predicate device. Clinical testing was not conducted in support of 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
Image /page/0/Picture/0 description: The image shows the word "BIOMET" in a stylized, blocky font. Above the word, there is a handwritten alphanumeric string "K063002". The word "BIOMET" is the main focus of the image, with the alphanumeric string appearing as a secondary element.
p. 1/2.
OCT 3 ] 2006
510(k) Summary
| Preparation Date: | September 29, 2006 |
|---|---|
| Applicant/Sponsor: | Biomet Manufacturing Corp. |
| 56 East Bell Drive | |
| Warsaw, Indiana 46582 | |
| Contact Person: | Gary Baker M.S. RAC |
| Regulatory Specialist | |
| Biomet Manufacturing Corp. | |
| Tel: (574) 267-6639 Extension 1568 | |
| Fax: (574) 372-1683 | |
| e-mail: gary.baker@biometmail.com | |
| Proprietary Name: | Altra™ Press-Fit Hip System |
Common Name: Common Hip Stem
Classification Code(s)/Name(s):
LZO - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis §888.3353.
KWA - Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis §888.3330
KWZ - Hip joint metal/polymer constrained cemented or uncemented prosthesis $888.3310
JDL - Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis $888.3320
JDI - Hip joint metal/polymer semi-constrained cemented prosthesis §888.3350 MAY - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis $888.3353.
MEH – Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis §888.3353.
LPH - Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis $888.3358
KWL - Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis 888.3360.
LWJ - Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis 888.3360.
KWY - Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis §888.3390
| 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
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
063002
Fine Grain Cast Cobalt Chromium Hip Stem - K953925
Device Description:
The Altra™ Press-Fit Hip System consists of a hip stem made from Ti-6AJ-4V titanium alloy conforming to ASTM F-136.
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 Altra™ Press-Fit Hip System is intended for uncemented use only.
Summary of Technologies:
The Altra™ Press-Fit Hip System incorporates a similar design with similar technological features as the predicate hip stem. It has the same intended use, indications for use, and utilizes the same Biomet Type I Taper as the predicate stems. These similarities demonstrate that the Altra™ Press-Fit Hip System is substantially equivalent to the predicate hip stem.
Non-Clinical Testing:
Mechanical testing demonstrated that the Altra™ Press-Fit Hip System is substantially equivalent to the predicate device.
Clinical Testing:
Clinical testing was not conducted in support of substantial equivalence.
All trademarks are property of Biomet, Inc.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 3 1 2006
Biomet Manufacturing Corp. % Mr. Gary Baker, M.S., RAC 56 East Bell Drive Warsaw, Indiana 46582
Re: K063002
Trade/Device Name: Altra Press-Fit Hip Stem 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 Codes: KWA, JDL, LZO, KWZ, JDI, MAY, MEH, LPH, KWL, LWJ, KWY Dated: September 29, 2006 Received: October 2, 2006
Dear Mr. Baker:
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 - Mr. Gary Baker, M.S., RAC
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
for Delbert
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KO6 3002
Indications for Use
510(k) Number (if known):
Device Name:__________________________________________________________________________________________________________________________________________________________________
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 4. proximal femur with head involvement, unmanageable using other techniques
-
- Revision of previously failed total hip arthroplasty.
The Altra™ Press-Fit Hip System is 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)
P.O. Thung
Division Sign Off
(Division Sign-Off Division of General, Restorative, and Neurological Livices
Page 1 of 1
510(k) Number L, 063006
3 - 1