(60 days)
No
The 510(k) summary describes a mechanical hip implant and its components. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies listed are mechanical tests, not software validation.
Yes
The device is a hip stem used for total hip replacement and hemiarthroplasty to treat various conditions like degenerative joint disease, arthritis, fractures, and deformities, which clearly indicates a therapeutic purpose.
No
Explanation: The device is a hip stem (implant) used in total hip replacement or hemiarthroplasty to treat various conditions, not to diagnose them.
No
The device description clearly outlines a physical hip stem and associated components, which are hardware. The performance studies also focus on mechanical testing of the hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes a surgical implant used to replace the femoral component of a hip joint. It is implanted directly into the patient's body.
- Lack of Specimen Analysis: There is no mention of analyzing any specimens taken from the body. The device's function is mechanical replacement of a joint component.
Therefore, based on the provided information, the Apex ARC™ Hip Stem is a surgical implant, not an In Vitro Diagnostic device.
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
LPH, LZO, MEH, KWY
Device Description
The Apex ARC Hip Stem consists of a curved, rectangular tapered stem, and modular necks that connect to the tapered hole in the stem. The height of the anterior and posterior lateral protrusions (Lateral T-Flange) was reduced on Size 1 and 2 ARC Hip Stems. Three new neck sizes are offered, Long Neutral, Long 8 ° Varus/Valgus and Anteverted. 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
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
Non-Clinical Test
The following tests were conducted:
- t Fatigue Strength Testing per ISO 7206-6, ISO-7206-4, ISO 7206-8 and ASTM 2068-09
- . ROM evaluation per ISO 21535
Clinical Test No clinical studies were performed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
JUN 2 7 2011
510(k) Summary
| Apex Hip System ARC ™ Hip Stem | 01June 2011 | |||
|---|---|---|---|---|
| Submitter | OMNIlife science, Inc. | |||
| 50 O'Connell Way | ||||
| E. Taunton MA 02718 | Contact | Radhika Pondicherry | ||
| Regulatory Affairs | ||||
| 774-226-1852 | ||||
| (508) 822-6030 (fax) | ||||
| Preparation Date | 01 June, 2011 | |||
| Device Name | ||||
| Trade Name | Apex Hip System | |||
| Apex ARC ™ Hip Stem, | ||||
| Sizes | Apex ARC Hip Stem, Size 1 | |||
| Apex ARC Hip Stem, Size 1 HA Coated | ||||
| Apex ARC Hip Stem, Size 2 | ||||
| Apex ARC Hip Stem, Size 2 HA Coated | ||||
| Apex ARC Hip System Modular Neck, Anteverted | ||||
| Apex ARC Hip System Modular Neck, Long Neutral | ||||
| Apex ARC Hip System Modular Neck, Long 8° Varus/Valgus | ||||
| 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 | ||||
| Product Code | Class II per 21 CFR § 888.3358, §888.3353, §888.3390 | |||
| 21 CFR Product Code- LPH, LZO, MEH, KWY | ||||
| Legally Marketed | ||||
| Predicate Device(s) | K090845- Apex ARC™ Hip Stem | |||
| Device Description | The Apex ARC Hip Stem consists of a curved, rectangular tapered stem, and modular necks that | |||
| connect to the tapered hole in the stem. The height of the anterior and posterior lateral | ||||
| protrusions (Lateral T-Flange) was reduced on Size 1 and 2 ARC Hip Stems. Three new neck sizes | ||||
| are offered, Long Neutral, Long 8 ° Varus/Valgus and Anteverted. 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. |
.
.
1
K111193/(Page 2 of 3)
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.
| | Apex ARC Hip Stem,
Additional necks and
Lateral T-Flange stem
design change
(subject device) | Apex ARC Hip Stem
(K090845) |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| Intended Use | | |
| Primary and revision total hip
replacement | Yes | Yes |
| Design | | |
| T-Flange | T-Flange was reduced by
half on the size 1 and size 2
ARC Hip Stem. | ARC Hip Stem T-flange
size 1 and size 2 |
| Stem Design | Curved, rectangular tapered
stem. | Curved, rectangular
tapered stem. |
| Neck Design | Long neutral, long 8 °
varus/valgus, anteverted | Neutral, 8° and 12 °
varus/valgus |
| Materials | | |
| Apex ARC Hip Stem | Identical to K090845 | Ti6Al4V
per ASTM F136 |
| Plasma spray Titanium
coating | Identical to K090845 | Unalloyed titanium
plasma spray
per ASTM F1580 |
| Hydroxyapatite Coating | Identical to K090845 | Hydroxyapatite plasma
spray coating
per ASTM F1185 |
| Apex ARC Modular Neck | Identical to K090845 | CoCr alloy |
Predicate Device Comparison
2
K1111193 (pg. 3 of 3)
| per ASTM F1537 | |||
|---|---|---|---|
| PACKAGING | AND | ||
| STERILIZATION | |||
| Sterilization | Identical to K090845 | Ethylene oxide | |
| SAL | Identical to K090845 | $10^{-6}$ | |
| Packaging | Identical to K090845 | Paper Board Box, Double | |
| Tyvek inner pouch |
Non-Clinical Test
The following tests were conducted:
Summary
The following tests were conducted
- t Fatigue Strength Testing per ISO 7206-6, ISO-7206-4, ISO 7206-8 and ASTM 2068-09
- . ROM evaluation per ISO 21535
Clinical Test No clinical studies were performed. Summary
- The addition of 3 new neck options; Long Neutral, Long 8 ° Varus/Valgus and Anteverted, and the Conclusions reduction of height of the anterior and posterior lateral protrusions (Lateral T-Flange) for the Size 1 and 2 ARC Hip Stems described in this submission are substantially equivalent to the predicate devices.
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
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 50 O'Connell Way East Taunton, Massachusetts 02718
JUN 2 7 2011
Re: K111193 Trade/Device Name: Apex ARCTM Hip Stem Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prothesis Regulatory Class: Class II Product Code: LZO, MEH, LPH, KWY Dated: June 1, 2011 Received: June 2, 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.
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
4
Page 2 – Ms. Radhika Pondicherry
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Eunel Keith
For Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number: K111193
Device Name: Apex Hip System 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 (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.
AND/OR Over-The-Counter Use Prescription Use (Part 21 CFR 801 Subpart D) (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
for M.Meikerson
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111193