(29 days)
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.
The Altra™ Press-Fit Hip System consists of a hip stem made from Ti-6AJ-4V titanium alloy conforming to ASTM F-136.
The provided document is a 510(k) summary for the Biomet Altra™ Press-Fit Hip System. It describes the device, its intended use, and claims substantial equivalence to a predicate device.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (Fine Grain Cast Cobalt Chromium Hip Stem - K953925) | Mechanical testing demonstrated that the Altra™ Press-Fit Hip System is substantially equivalent to the predicate device. |
| Similar Design & Technological Features | The Altra™ Press-Fit Hip System incorporates a similar design with similar technological features as the predicate hip stem. |
| Same Intended Use & Indications for Use | It has the same intended use, indications for use. |
| Utilizes Same Biomet Type I Taper | Utilizes the same Biomet Type I Taper as the predicate stems. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "Clinical testing was not conducted in support of substantial equivalence." Therefore, there is no test set sample size or data provenance to report for clinical performance. The evaluation was based on non-clinical (mechanical) testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No clinical testing was performed, so no experts were needed to establish ground truth for a clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical testing was performed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a medical implant (hip system), not an AI-powered diagnostic device. Therefore, an MRMC study related to human reader performance with AI assistance is irrelevant and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical implant (hip system), not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical testing, the "ground truth" was established by engineering specifications and established mechanical testing standards to demonstrate substantial equivalence to the predicate device. For example, mechanical properties like fatigue strength, wear resistance, and construct stability would have been compared against the predicate and relevant standards. The document doesn't specify the exact standards but refers to "Mechanical testing".
8. The sample size for the training set
Not applicable. This device is a medical implant, not a machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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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 DriveWarsaw, Indiana 46582 |
| Contact Person: | Gary Baker M.S. RACRegulatory SpecialistBiomet Manufacturing Corp.Tel: (574) 267-6639 Extension 1568Fax: (574) 372-1683e-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 587Warsaw, IN 46581 0587 |
|---|---|
| SHIPPING ADDRESS | 56 E. Bell DriveWarsaw, IN 46582 |
| OFFICE | 574.267.6639 |
| FAX | 574.267.8137 |
| 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
§ 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.