(89 days)
No
The device description and intended use are for a physical implant (femoral head) and do not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes.
The device is specifically designed for use in total hip replacement procedures to correct various conditions like degenerative joint disease, rheumatoid arthritis, and functional deformity, which are therapeutic interventions.
No
This device is an implantable component for total hip replacement procedures, not a diagnostic tool. Its purpose is to replace a damaged femoral head, not to diagnose a condition.
No
The device description clearly states it is a physical component (femoral head) made of ceramic material, intended for surgical implantation. It is not software.
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: The description clearly states that the Apex Modular™ Alumina Femoral Head is a physical implant made of ceramic material. It is intended to be surgically implanted into the hip joint.
- Intended Use: The intended use describes the device's function as a component in total hip replacement surgery, replacing a damaged part of the femur. This is a surgical procedure, not a diagnostic test performed on a sample outside the body.
The device is a surgical implant used in a therapeutic procedure, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Apex Modular™ Alumina Femoral Head is intended for use in combination with the Apex Modular Hip Stem as the femoral component in total hip replacement procedures. This ceramic head is intended to articulate with a polyethylene or metal-backed polyethylene acetabular cup component. This prosthesis is intended for single use implantation, and 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
LZO
Device Description
The Apex Modular™ Alumina Heads are manufactured of Biolox® forte alumina (high purity aluminum oxide ceramic) by CeramTec AG (Biolox® is a registered trademark of CeramTec AG). The bore on this ball was designed and tested for compatibility with the neck taper on the Apex Modular Hip Stem (K000788). These modular heads are available in 28 mm and 32 mm diameters, with three offset options for each head size: -3.5, 0, and +3.5 mm (28 mm diameter heads) and -4, 0, and +4 mm (32 mm diameter heads).
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Burst and fatigue testing of these alumina heads on the Apex Modular 12/14 taper have been completed as per the relevant FDA guidance document.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
Apex Modular™ Alumina Femoral Head
| 1. Submitter: | Apex Surgical, LLC
12 Harding Street
Suite 202
Lakeville, MA 02347 | Contact |
| --------------- | ----------------------------------------------------------------------------- | --------- |
|---|
2. Device Name
| Proprietary Name: | Apex Modular™ Alumina Femoral Head |
|---|---|
| Common Name: | Ceramic femoral head |
| Classification Name: | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis |
| Regulatory Class: | Class II per 21 CFR §888.3353 |
3. Intended Use
The Apex Modular™ Alumina Femoral Head is intended for use in combination with the Apex Modular Hip Stem as the femoral component in total hip replacement procedures. This ceramic head is intended to articulate with a polyethylene or metal-backed polyethylene acetabular cup component. This prosthesis is intended for single use implantation, and 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 Modular™ Alumina Heads are manufactured of Biolox® forte alumina (high purity aluminum oxide ceramic) by CeramTec AG (Biolox® is a registered trademark of CeramTec AG). The bore on this ball was designed and tested for compatibility with the neck taper on the Apex Modular Hip Stem (K000788). These modular heads are available in 28 mm and 32 mm diameters, with three offset options for each head size: -3.5, 0, and +3.5 mm (28 mm diameter heads) and -4, 0, and +4 mm (32 mm diameter heads).
August 27, 2000
Edward J. Cheal, Ph.D. Managing Director (508) 947-6500 (voice) (208) 248-8227 (fax)
510(K) Summary KO12918
NOV 2 7 2001
Image /page/0/Picture/18 description: The image shows the logo for Apex Surgical. The logo consists of a large, bold letter "A" followed by the words "Apex Surgical" in a slightly smaller font. The letters are all black, and the word "Surgical" has a trademark symbol next to it.
1
Image /page/1/Picture/1 description: The image shows the logo for Apex Surgical. The logo consists of a large, stylized letter "A" on the left, followed by the words "Apex Surgical" in a bold, sans-serif font. The letters are all black, and there is a small trademark symbol to the upper right of the word "Surgical".
5. Predicate Device Comparison
Substantial equivalence is claimed to the Smith & Nephew Biolox Alumina Ceramic Heads and the Plus Orthopedics Biolox® forte Alumina Ceramic Heads. The table below r rodus and the features and characteristics of the Apex Modular Alumina Femoral Head to these predicate devices.
| | Apex Modular
Alumina
Femoral Head | Smith &
Nephew Biolox
Alumina
Ceramic Heads
(K981847 and
K991162) | Plus
Orthopedics
Biolox® forte
Alumina Heads
(K990261) |
|-----------------------------------------------|-----------------------------------------|----------------------------------------------------------------------------------|--------------------------------------------------------------------|
| INTENDED USE | | | |
| Primary and revision
total hip replacement | Yes | Yes | Yes |
| DESIGN | | | |
| Taper design | 12/14 | 12/14 | 12/14 |
| Head diameters | 28 and 32 mm | 28 and 32 mm | 28 and 32 mm |
| Offsets, 28 mm heads | -3.5, 0, +3.5 mm | 0, +3.5, +7 mm | -3.5, 0, +3.5 mm |
| Offsets, 32 mm heads | -4, 0, +4 mm | 0, +4, +8 mm | -4, 0, +4 mm |
| MATERIALS | | | |
| Ceramic head | Alumina | Alumina | Alumina |
| Stem trunion | Titanium alloy | Ti alloy or CoCr | Ti alloy or CoCr |
These predicate heads are produced by the same vendor (CeramTec AG), using the same material (Biolox® forte), as the subject device. Burst and fatigue testing of these alumina heads on the Apex Modular 12/14 taper have been completed as per the relevant FDA guidance document.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/13 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing right, with flowing lines representing movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 7 2001
Edward J. Cheal, Ph.D. Managing Director Apex Surgical, LLC 12 Harding Street, Suite 202 Lakeville, Massachusetts 02347
Re: K012918
Trade/Device Name: Apex Modular Alumina Femoral Head Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis
Regulatory Class: II Product Code: LZO Dated: August 27, 2001 Received: August 30, 2001
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 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 - Edward J. Cheal, Ph.D.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Mark N. Milken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications For Use Device Name: Apex Modular™ Alumina Femoral Head KO12918
The Apex Modular™ Alumina Femoral Head is intended for use in combination with the The Apex Modular Hip Stem as the femoral component in total hip replacement procedures. Apex Modular Hip Otom as the rended to articulate with a polyethylene or metal-backed This ceramic nead in intended to annonent. This prosthesis is intended for single use implantation, and may be used for the following conditions, as appropriate:
- ation, and may be decenerative joint disease, including osteoarthritis and . avascular necrosis;
- Rheumatoid arthritis; .
- Correction of functional deformity; ●
- Congenital dislocation; .
- Oongonitar arocedures where other treatments or devices have failed; .
- Femoral neck and trochanteric fractures of the proximal femur. .
(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N Millman
sion of General, Restorative
51 ( ) Number.
OR
Prescription Use X (Per 21 CFR §801.109) Over-the-Counter Use
(Optional Format 1-2-96)