(73 days)
Not Found
No
The summary describes a mechanical hip implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a hip stem used in total hip replacement and hemiarthroplasty to treat various medical conditions, indicating a therapeutic purpose.
No
The text describes the Apex Hip System K1 Hip Stem as a femoral component for hip replacement surgery. Its intended use is for treating various conditions that necessitate a hip replacement, such as degenerative joint disease, rheumatoid arthritis, and fractures. This is a therapeutic device designed for implantation and not for diagnosing a condition.
No
The device description clearly indicates it is a physical hip stem, a hardware component for total hip replacement.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a femoral component of a total hip replacement or hemiarthroplasty. This is a surgical implant used in the body to replace a joint.
- Device Description: The description details the physical characteristics of a hip stem (rectangular, tapered, sizes, neck offsets).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue) to provide information about a physiological state, health, disease, or congenital abnormality.
IVD devices are used outside the body to perform tests on biological samples. This device is a surgical implant used inside the body.
N/A
Intended Use / Indications for Use
The Apex Hip System K1™ Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement when used with the Apex Interface™ Acetabular System. The Apex Interface™ Acetabular System articulates with the Apex Modular Femoral Head (Cobalt Chromium or Ceramic). The femoral hip stem is intended for uncemented fixation and single use implantation. These prosthesis may be used for hip arthroplasty to treat 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.
The Apex Hip System K1 Femoral Stem is also intended for use in hemiarthroplasty when used with the Apex Bipolar Head.
The Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System femoral stem for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:
- Femoral neck and trochanteric fractures of the proximal femur;
- · Osteonecrosis of the femoral head;
- Revision procedures where other treatments or devices for these indications have failed.
Product codes (comma separated list FDA assigned to the subject device)
LPH, LZO, KWY
Device Description
The Apex K1™ Hip Stems are rectangular in cross-section and tapered in the proximal-to-distal direction. The K1 Hip Stem is offered in 12 sizes and two neck offsets for each size. Standard necks have a 135 degree angle and lateralized (Lat) necks have a 130 degree angle. Sizes 7 to 12 also offer a Lat + offset with a 127 degree angle.
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)
Non-Clinical Test Summary
The following tests were conducted:
- . Fatigue Strength Testing per ISO 7206-6, ISO-7206-4, ISO 7206-8 and ASTM 2068-09
- . ROM evaluation per ISO 21535
Clinical Test Summary No clinical studies were performed.
Conclusions The Apex K1 Stems, sizes 0, 0 Lat, 1, 1 Lat, Lat + stems sizes 7,8,9,10,11 and 12 are substantially equivalent to the predicate devices.
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
§ 888.3358 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
JUN 1 6 2011
| 510(K) Summary JUN 16 2011 | |
|---|---|
| 16 April, 2011 | |
| Submitter | Contact |
| OMNIlife science, Inc. | |
| 50 O'Connell Way | |
| E. Taunton MA 02718 | Radhika Pondicherry |
| Regulatory Affairs | |
| 774-226-1852 | |
| (508) 822-6030 (fax) | |
| Preparation Date | 16 April, 2011 |
| Device Name | Apex Hip System |
| Trade Name | Apex K1 ™ Hip Stem, |
| Sizes | Apex K1™ Hip Stem, Size 0 |
| Apex K1™ Hip Stem, Size 0 Lat | |
| Apex K1™ Hip Stem, Size 1 | |
| Apex K1™ Hip Stem, Size 1 Lat | |
| Apex K1™ Hip Stem, Size 7 Lat + | |
| Apex K1™ Hip Stem, Size 8 Lat + | |
| Apex K1™ Hip Stem, Size 9 Lat + | |
| Apex K1™ Hip Stem, Size 10 Lat + | |
| Apex K1™ Hip Stem, Size 11 Lat + | |
| Apex K1™ Hip Stem, Size 12 Lat + | |
| Common name/ | |
| Classification | Hip joint metal/polymer/metal semi-constrained porous-coated uncemented |
| prosthesis | |
| Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous | |
| uncemented prosthesis. | |
| Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented | |
| prosthesis. | |
| Regulatory Class | Class II per 21 CFR §888.3358, §888.3353, §888.3390 |
| Product Code | LPH, LZO, KWY |
| Legally Marketed | |
| Predicate Device(s) | K060072- Apex K1™ Hip Stem |
| Device Description | The Apex K1™ Hip Stems are rectangular in cross-section and tapered in the |
| proximal-to-distal direction. The K1 Hip Stem is offered in 12 sizes and two | |
| neck offsets for each size. Standard necks have a 135 degree angle and | |
| lateralized (Lat) necks have a 130 degree angle. Sizes 7 to 12 also offer a Lat + | |
| offset with a 127 degree angle. | |
| Indications for Use | The Apex Hip System K1™ Hip Stem is intended for use as the femoral |
| component of a primary or revision total hip replacement when used with the | |
| Apex Interface™ Acetabular System. The Apex Interface™ Acetabular System | |
| articulates with the Apex Modular Femoral Head (Cobalt Chromium or | |
| Ceramic). The femoral hip stem is intended for uncemented fixation and | |
| single use implantation. These prosthesis may be used for hip arthroplasty to | |
| treat the following conditions, as appropriate: | |
| • Non-inflammatory degenerative joint disease, including | |
| osteoarthritis and avascular necrosis; | |
| • Rheumatoid arthritis; | |
| • Correction of functional deformity; |
រ
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·
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p. 2/2
- · Congenital dislocation;
- · Revision procedures where other treatments or devices have failed;
- · Femoral neck and trochanteric fractures of the proximal femur.
The Apex Hip System K1 Femoral Stem is also intended for use in hemiarthroplasty when used with the Apex Bipolar Head.
The Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System femoral stem for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:
- · Femoral neck and trochanteric fractures of the proximal femur;
- · Osteonecrosis of the femoral head;
- · Revision procedures where other treatments or devices for these indications have failed.
| | Apex K1 Hip Stem,
size 0, 0 Lat, 1, 1 Lat
and 7 thru 12 Lat +
(subject device) | Apex K1 Hip Stem,
Sz 2 to 12
(K060072) |
|-----------------------------------------------|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Intended Use | Yes | Yes |
| Primary and revision
total hip replacement | Yes | Yes |
| Design | | |
| Stem Design | Identical to K060072 | Rectangular in cross-
section and tapered in the
proximal-to-distal
direction |
| Materials | | |
| K1 Stem | Identical to K060072 | Ti6Al4V per ASTMF136 |
| Plasma spray
Titanium coating | Identical to K060072 | Ti Coating per ASTM F1580 |
| PACKAGING AND
STERILIZATION | | |
| Sterilization | Identical to K060072 | Ethylene oxide |
| Sal | Identical to K060072 | 10-6 |
| Packaging | Identical to K060072 | Paper Board Box, Double
Tyvek inner pouch |
Non-Clinical Test Summary
The following tests were conducted:
- . Fatigue Strength Testing per ISO 7206-6, ISO-7206-4, ISO 7206-8 and ASTM 2068-09
- . ROM evaluation per ISO 21535
Clinical Test Summary No clinical studies were performed.
Conclusions The Apex K1 Stems, sizes 0, 0 Lat, 1, 1 Lat, Lat + stems sizes 7,8,9,10,11 and 12 are substantially equivalent to the predicate devices.
Predicate Device Comparison
2
Image /page/2/Picture/0 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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a bird-like figure with three lines forming the body and wings.
Food.and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OMNIlife Science, Inc. % Ms. Radhika Pondicherry Regulatory Affairs Specialist 50 O'Connell Way East Taunton, Massachusetts 02718
JUN 1 6 2011
Re: K110947 Trade/Device Name: Apex K 1 Hip System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, LZO, KWY Dated: May 17, 2011 Received: May 18, 2011
Dear Ms. Pondicherry:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical
3
Page 2 - Ms. Radhika Pondicherry
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: K110947
Device Name: Apex K1™ Hip System
The Apex Hip System K1™ Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement when used with the Apex Interface™ Acetabular System. The Apex Interface™ Acetabular System articulates with the Apex Modular Femoral Head (Cobalt Chromium or Ceramic). The femoral hip stem is intended for uncemented fixation and single use implantation. These prosthesis may be used for hip arthroplasty to treat 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.
The Apex Hip System K1 Femoral Stem is also intended for use in hemiarthroplasty when used with the Apex Bipolar Head.
The Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System femoral stem for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:
- Femoral neck and trochanteric fractures of the proximal femur;
- · Osteonecrosis of the femoral head;
- Revision procedures where other treatments or devices for these indications have failed.
AND/OR Over-The-Counter Use Prescription Use x (Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
Page 1 of 1
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Emil Reith
f Surgical, Orthopedic,
510(k) Number K110947