(64 days)
Not Found
No
The summary describes a mechanical hip implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a hip stem intended for use in total hip replacement and hemiarthroplasty to treat various conditions, which are therapeutic interventions.
No
This device is a hip implant, specifically a femoral component, used for hip replacement surgery. It is a therapy device, not a diagnostic one.
No
The device description clearly details a physical hip stem made of titanium alloy and modular necks made of cobalt chromium alloy, intended for surgical implantation. This is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing the femoral component of a hip joint. This is a medical device used in vivo (within the body) for structural support and function.
- Device Description: The description details the physical components of a hip stem (stem, necks, materials like titanium alloy and cobalt chromium alloy). These are physical implants, not reagents, instruments, or systems used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting diseases or conditions through laboratory tests, or providing information for diagnosis based on in vitro analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used to treat a physical condition directly.
N/A
Intended Use / Indications for Use
The Apex ARC™ 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 prostheses 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 ARC™ Hip 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, MEH, KWY
Device Description
The Apex ARC Hip Stem consists of a curved, rectangular tapered stem with a distal slot, and modular necks that connect to the tapered hole in the stem. The larger size stems have a lateral feature referred to as a lateral t-flange. The T-flange is reduced in size on the smaller stem sizes (size 1 and 2), and further reduced to no t-flange on the smallest (subject) size 0 stem. The femoral stems are manufactured from titanium alloy and the modular necks are manufactured from cobalt chromium alloy. The Apex ARC Hip Stem is available with and without HA coating.
The necks are compatible with the Cobalt Chromium and Ceramic modular heads, and may be used with head diameters and offsets up to a maximum offset of +7 mm. The Apex ARC Hip Stem may be used in conjunction with the Apex Interface™ Acetabular System (Shells and Inserts) for total hip arthroplasty.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, femoral component of a primary, or revision total hip replacement, proximal femur
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)
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
No clinical studies were performed.
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.
Apex ARC Hip Stem (K090845), Apex ARC Hip Stem (K111193)
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
:
Apex ARC ™ Hip Stem
7 December, 2011
| Submitter | OMNIlife science, Inc.
50 O'Connell Way
E. Taunton MA 02718 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Christine Nassif
Director, Regulatory Affairs
774-226-1871
(508) 822-6030 (fax) |
| Preparation Date | 7 December, 2011 |
| Device Name | Apex Hip System |
| Trade Name | Apex ARC ™ Hip Stem |
| Sizes | Apex ARC Hip Stem, Size O
Apex ARC Hip Stem, Size 0 HA Coated |
| 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 |
| Regulatory Class | Class II per 21 CFR § 888.3358, §888.3353, § 888.3390 |
| Product Code | LPH, LZO, MEH, KWY |
| Legally Marketed Predicate Device(s) | Apex ARC Hip Stem (K090845), Apex ARC Hip Stem (K111193) |
| Device Description | The Apex ARC Hip Stem consists of a curved, rectangular tapered stem with a distal slot, and modular necks that connect to the tapered hole in the stem. The larger size stems have a lateral feature referred to as a lateral t-flange. The T-flange is reduced in size on the smaller stem sizes (size 1 and 2), and further reduced to no t-flange on the smallest (subject) size 0 stem. The femoral stems are manufactured from titanium alloy and the modular necks are manufactured from cobalt chromium alloy. The Apex ARC Hip Stem is available with and without HA coating.
The necks are compatible with the Cobalt Chromium and Ceramic modular heads, and may be used with head diameters and offsets up to a maximum offset of +7 mm. The Apex ARC Hip Stem may be used in conjunction with the Apex Interface™ Acetabular System (Shells and Inserts) for total hip arthroplasty. |
Page 1 of 2
1
| Indications for
Use | The Apex ARC™ 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 prostheses
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 ARC™ Hip 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. |
| Predicate Device
Comparison | The Apex ARC Hip Stem is manufactured, packaged, and sterilized using equivalent materials
and processes. The subject device(s) is also substantially equivalent to its predicate(s) based
on comparison of design features, intended use, and indications for use. The fundamental
scientific technology of the modified device(s) has not changed relative to the predicate
device(s). The safety and effectiveness of the devices has not changed relative to the
predicate devices. The safety and effectiveness of the Apex ARC Hip Stem is adequately
supported by the substantial equivalence information, materials information, and analysis
data provided within this Premarket Notification. |
| 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 addition of one new stem size for the Apex ARC Hip Stem, in our opinion, is substantially
equivalent to the predicate device. |
Page 2 of 2
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is an abstract image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
OMNIlife Science Inc. % Ms. Christine Nassif 50 O'Connell Way East Taunton, MA 02718 US
JAN - 5 2012
Re: K113242
Trade/Device Name: Apex ARC Hip Stem 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, MEH, KWY Dated: December 7, 2011 Received: December 8, 2011
Dear Ms. Christine Nassif:
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 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.
3
Page 2 - Ms. Christine Nassif
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/ResourcesforYou/Industry/default.htm.
Sincerely yours!
Mark N. Mellon
Mark N. Melkerson Director Division of Surgical. Orthopedic & Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
્રીડિટનડ
Indications for Use
510(k) Number (if known):
Device Name: Apex ARC Hip System
The Apex ARC™ 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 (Cobait Chromium or Ceramic). The femoral hip stem is intended for uncemented fixation and single use implantation. These prostheses 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 ARC™ Hip 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 hemiathroplasty 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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Division Sign-Off)
Division of surgical, Orthopedic, and Restorative Devices
510(k) Number K113242
Special 510(k) Apec ARC Hip Stem-Size 0