(227 days)
No
The 510(k) summary describes a mechanical hip stem and its components, with no mention of AI, ML, image processing, or any software-driven features that would typically incorporate such technologies.
Yes
This device is intended to treat multiple medical conditions such as non-inflammatory degenerative joint disease, rheumatoid arthritis, avascular necrosis, and femoral neck and trochanteric fractures of the proximal femur.
No
The device description indicates that the Apex K1™ Hip Stem is an implantable prosthesis used as the femoral component in hip replacement surgery, not for diagnosing conditions.
No
The device description clearly states it is a physical hip stem made of titanium alloy, which is a hardware component.
Based on the provided information, 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: The Apex K1 Hip Stem is a physical implantable device (a femoral component for hip replacement surgery). It is surgically placed within the patient's body.
- Intended Use: The intended use is to replace a damaged or diseased femoral component in a hip joint, which is a surgical procedure, not a diagnostic test performed on a sample outside the body.
The information clearly describes a medical device used for surgical intervention and replacement of a body part, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Apex K1™ Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate:
- . Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis; .
- Correction of functional deformity: .
- . Congenital dislocation;
- Revision procedures where other treatments or devices have failed: .
- . Femoral neck and trochanteric fractures of the proximal femur.
Product codes
LPH, LZO
Device Description
The Apex K1 Hip Stem consists of a rectangular tapered stem, and modular heads that connect to the tapered trunion on the neck. Four configurations are available for each size: standard and long lengths, each with standard and lateraliz ed necks. These configurations allow the user to choose a combination of stem and head components to appropriately fit the anatomy of the patient. The Apex K1 Hip Stem may be used in conjunction with the Apex Modular™ Acetabular Cup (K031110) for total hip arthroplasty.
The femoral stems are manufactured from titanium alloy, and can be used with the cobalt chromium alloy heads and the alumina ceramic heads that are part of the Apex Modular and Apex K2 hip systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
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
510(K) Summary
AUG 2 5 2006
K060072
Apex K1™ Hip Stem
April 13, 2006
Contact: Edward J. Cheal, Ph.D. 1. Submitter: OMNI life science, Inc. 1390-A Decision Street Vice President of Research Vista. CA 92081 (760) 734-1550 x413
2. Device Name
| Proprietary Name: | Apex K1™ Hip Stem |
|---|---|
| Common Name: | Hip prosthesis, uncemented |
| Classification Names: | Hip prosthesis, semi-constrained, metal/polymer, and hip joint |
| metal/ceramic/polymer, uncemented prosthesis | |
| Regulatory Class: | Class II per 21 CFR §888.3358 and §888.3353 |
| Product Codes: | LPH and LZO |
3. Intended Use
The Apex K1™ Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate:
- . Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis; .
- Correction of functional deformity: .
- . Congenital dislocation;
- Revision procedures where other treatments or devices have failed: .
- . Femoral neck and trochanteric fractures of the proximal femur.
4. Device Description
The Apex K1 Hip Stem consists of a rectangular tapered stem, and modular heads that connect to the tapered trunion on the neck. Four configurations are available for each size: standard and long lengths, each with standard and lateraliz ed necks. These configurations allow the user to choose a combination of stem and head components to appropriately fit the anatomy of the patient. The Apex K1 Hip Stem may be used in conjunction with the Apex Modular™ Acetabular Cup (K031110) for total hip arthroplasty.
The femoral stems are manufactured from titanium alloy, and can be used with the cobalt chromium alloy heads and the alumina ceramic heads that are part of the Apex Modular and Apex K2 hip systems.
1
Image /page/1/Picture/1 description: The image shows the OMNI logo on the left side and the text "510(K) Summary" and "K060072" on the right side. The OMNI logo consists of the word "OMNI" in bold black letters and a circular graphic above it. The text "510(K) Summary" is in a smaller font size than the word "OMNI", and the text "K060072" is in a larger font size and is located below the text "510(K) Summary". A black line is present below the word "OMNI".
5. Predicate Device Comparison
Substantial equivalence is claimed to the SL-Plus® and SLR-Plus® hip stems distributed by Plus Orthopedics (K001942 and K021178), a nd the Apex K2™ Hip System (K041950). The table below compares the features and characteristics of the Apex K1 Hip Stem to these predicate devices:
| | Apex K1™ Hip
Stem | Apex K2™ Hip
Stem (K041950) | SL-Plus® and
SLR-Plus®
(K001942, K021178) |
|---------------------------------------------------------------|-------------------------------|--------------------------------|-------------------------------------------------|
| INTENDED USE | | | |
| Primary and revision
hip replacement, non-
cemented use | Yes | Yes | Yes |
| DESIGN | | | |
| Coated | Yes - plasma
sprayed CP Ti | Yes - plasma
sprayed CP Ti | No |
| Proximal coating (only) | Yes | Yes | NA |
| Modular head | Yes | Yes | Yes |
| Surface finish | Al-oxide grit blast | Al-oxide grit blast | Al-oxide grit blast |
| Modular neck | No | Yes | No |
| Tapered stem | Yes | Yes | Yes |
| Distal Cross-sectional
shape | Rectangular | Rectangular | Rectangular |
| Distal slot(s) | No | No | No |
| Distal flutes | No | No | No |
| MATERIALS | | | |
| Titanium alloy stem | Yes (Ti-6Al-4V) | Yes (Ti-6Al-4V) | Yes (Ti-6Al-7Nb) |
| Cobalt chromium or
alumina ceramic heads | Yes (both) | Yes (both) | Yes (both) |
| Titanium coating | Yes - unalloyed | Yes - unalloyed | No |
The Apex K1 stem geometry is similar to the SL-Plus® and SLR-Plus® distributed by Plus Orthopedics. The most significant difference between these devices is that the Apex K2 stems employ modular necks (and heads), while the SL-Plus and SLR-Plus, and the subject device, have modular heads (only). Also the Apex K2 and Apex K1 stems have a plasma sprayed CP titanium coating on the proximal portion of the stem, whereas the SL-Plus and SLR-Plus stems are grit blasted with no plasma sprayed coating.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 5 2006
Dr. Edward J. Cheal Vice President of Research OMNI life science, Inc. 1390-A Decision Street Vista, California 92081
K060072 Re:
Trade/Device Name: Apex K1 Hip Stem Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Codes: LZO, LPH Dated: August 21, 2006 Received: August 22, 2006
Dear Dr. Cheal:
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
3
Page 2 - Dr. Edward J. Cheal
ું.
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. 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,
Mark N. Melkerson, M.S. 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): K060072
Device Name: Apex K1™ Hip Stem
Indications For Use:
ﺮ ﭘﺮ
The Apex K1 Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate:
- Non-inflammatory degenerative joint disease, including osteoarthritis and . avascular necrosis;
- Rheumatoid arthritis; ●
- Correction of functional deformity; .
- Congenital dislocation; .
- Revision procedures where other treatments or devices have failed; ●
- Femoral neck and trochanteric fractures of the proximal femur. .
Prescription Use X (Per 21 CFR 801 Subpart D) Over-The-Counter Use_ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Oarbara Buchnd of
Page 1 of 1
Division of General, Restorative, and Neurological Devices
510(k) Number K060072