(376 days)
No
The device description and performance studies focus on the mechanical properties and compatibility of the hip stem components, with no mention of AI or ML.
Yes
The device is a hip stem intended to replace a damaged femoral component of a hip, which directly addresses disease conditions and restores function.
No
The device is a femoral component of a total hip replacement, which is a medical implant used for treatment, not diagnosis. It does not identify or detect diseases or conditions.
No
The device description clearly states it is a physical hip stem made of titanium and cobalt chromium alloys, intended for surgical implantation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The provided text clearly describes a femoral hip stem, which is an implantable medical device used in total hip replacement surgery. Its purpose is to replace a damaged or diseased part of the femur (thigh bone).
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is purely mechanical and structural within the body.
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. 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
LZO, MEH, LPH
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 femoral stems are manufactured from titanium alloy and the modular necks are manufactured from cobalt chromium alloy. Three neck sizes are offered, with a neutral, 8 degree, and 12 degree varus-valgus angle, respectively. The necks are compatible with the modular heads that are part of the Apex Modular and Apex K2 hip systems (K000788, K012918, and K073150) and may be used with head diameters and offsets up to a maximum offset of +7 mm. These configurations allow the user to choose a combination of stem, neck, and head components to appropriately fit the anatomy of the patient. The Apex ARC Hip Stem may be used in conjunction with the Apex Modular™ Acetabular Cup (K031110, K062489, and K073150) for total hip arthroplasty.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral component of a primary or revision total hip replacement
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:
- Distal fatigue strength per ISO 7206-4:1989, ISO 7206-8:1992, and ASTM 2068-. 09.
- Fretting potential per ISO 17853:2003. .
- Disassembly strength after fatigue testing per ASTM F2009-00. .
- Proximal fatigue strength per ISO 7206-6:1992 and ASTM 2068-09. .
- Torsional strength of the modular neck. .
- Range of motion per ISO 21535:2007. .
- Burst test, fatigue test, post-fatigue burst test, pull-off, and rotational stability of . the worst case modular neck-ceramic head combination per FDA Guidance for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems, and ISO 7206-10:2003.
- ETO Residuals per ANSI/AAMI/ISO 10993-7. .
- The Hydroxyapatite coating was previously cleared in K043123 .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K000788, K012918, K073150, K031110, K062489, K073150, K043123
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
Image /page/0/Picture/1 description: The image shows the logo for OMNIlife science. The logo consists of a circular graphic above the company name. The graphic appears to be a stylized representation of a cell or a similar biological structure. The text "OMNIlife science" is written in a bold, sans-serif font, with the word "OMNI" in a larger size than "life science".
510(K) Summary K090845
Apex ARC™ Hip Stem
April 7, 2010
| 1.Submitter | OMNI life science, Inc
50 O'Connell Way
E. Taunton, MA 02718 |
|-------------|--------------------------------------------------------------------|
| Contact: | Robert Zoletti
VP Regulatory Affairs
774-226-1845 |
| 2. Device Name | Apex ADCM Hip Stem |
|---|---|
| ---------------- | -------------------- |
| Proprietary Name: | Apex ARC TM Hip Stem |
|---|---|
| Common Name: | Hip prosthesis, uncemented |
| Classification Name: | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis |
| Regulatory Class: | Class II per 21 CFR §888.3353 and §888.3358 |
| Product Codes: | LZO, MEH, and LPH |
| 3. Legally Marketed Predicate Device | K041950 - Apex K2, K071946, K083495 - Aesculap Metha® |
| 4. 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 femoral stems are manufactured from titanium alloy and the modular necks are manufactured from cobalt chromium alloy. Three neck sizes are offered, with a neutral, 8 degree, and 12 degree varus-valgus angle, respectively. The necks are compatible with the modular heads that are part of the Apex Modular and Apex K2 hip systems (K000788, K012918, and K073150) and may be used with head diameters and offsets up to a maximum offset of +7 mm. These configurations allow the user to choose a combination of stem, neck, and head components to appropriately fit the anatomy of the patient. The Apex ARC Hip Stem may be used in conjunction with the Apex Modular™ Acetabular Cup (K031110, K062489, and K073150) for total hip arthroplasty. |
| 5. Intended Use | The Apex ARC™ 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. |
| 6. Predicate Device Comparison | Substantial equivalence is claimed to the Apex K2™ Hip System (distributed by OMNI life science, Inc.) and the Metha® Hip System (distributed by Aesculap Implant Systems, Inc.). The table below compares the features and characteristics of the Apex ARC Hip Stem to these predicate devices: |
1
510(K) Summary K090845
Image /page/1/Picture/1 description: The image shows the logo for Omni Life Science. The logo features a stylized eye-like symbol above the company name. The eye symbol is composed of concentric circles, with the innermost circle being white and the outer circles being black. The text "OMNI life science" is written in a bold, sans-serif font below the eye symbol.
| Apex ARC™ | Apex K2™ | Aesculap Metha® | |
|---|---|---|---|
| FDA 510(k)'s | K041950 | K071916 and K083495 | |
| INTENDED USE | |||
| Primary and revision hip replacement, | |||
| non-cemented | Yes | Yes | Yes |
| DESIGN | |||
| Circumferential porous coating | Yes - plasma | ||
| sprayed CP Ti | Yes - plasma | ||
| sprayed CP Ti | Yes - plasma sprayed | ||
| CP Ti | |||
| Proximal coating (only) | Yes | Yes | Yes |
| Modular head | Yes | Yes | Yes |
| Modular neck | Yes | Yes | Yes |
| Tapered stem | Yes | Yes | Yes |
| Cross-sectional shape | Rectangular | Rectangular | Rectangular/ rounded |
| Distal slot(s) | Yes | No | No |
| Distal flutes | No | No | No |
| MATERIALS | |||
| Titanium alloy (Ti6Al4V) stem | Yes | Yes | Yes |
| Cobalt chromium modular neck | Yes | No - titanium alloy | Yes |
| Cobalt chromium or alumina ceramic | |||
| heads | Yes (both) | Yes (both) | Yes (both) |
| Titanium porous coating | Yes - unalloyed | Yes - unalloyed | Yes - unalloyed |
| Hydroxyapatite overcoat option | Yes | No | Yes - calcium |
| phosphate |
The most significant difference between these devices is that the subject Apex ARC hip stem and the predicate Aesculap Metha hip stem both employ cobalt chromium modular necks with a tapered junction between the neck and the stem, whereas the Apex K2 stem system employs titanium alloy modular necks with a cylindrical press-fit junction and alignment pin.
- Non-Clinical Test Summary The following tests were conducted:
- Distal fatigue strength per ISO 7206-4:1989, ISO 7206-8:1992, and ASTM 2068-. 09.
- Fretting potential per ISO 17853:2003. .
- Disassembly strength after fatigue testing per ASTM F2009-00. .
- Proximal fatigue strength per ISO 7206-6:1992 and ASTM 2068-09. .
- Torsional strength of the modular neck. .
- Range of motion per ISO 21535:2007. .
- Burst test, fatigue test, post-fatigue burst test, pull-off, and rotational stability of . the worst case modular neck-ceramic head combination per FDA Guidance for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems, and ISO 7206-10:2003.
- ETO Residuals per ANSI/AAMI/ISO 10993-7. .
- The Hydroxyapatite coating was previously cleared in K043123 .
- Clinical Test No clinical studies were performed. Summary
The Apex ARC™ is substantially equivalent to the predicate devices. 9. Conclusions Nonclinical and Clinical
OMNI Apex ARC
K090845-S3-Page 1 of 2
2
Image /page/2/Picture/12 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
OMNI life science, Inc. % Mr. Robert Zoletti · Vice President Regulatory Affairs 50 O'Connell Way E. Taunton, Massachusetts 02718
APR - 7 2010
Re: K090845 Trade/Device Name: - Apex ARCTM Hip Stem Regulation Number: 21 CFR 8888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prothesis Regulatory Class: II Product Code: LZO, MEH, LPH Dated: March 31, 2010 Received: April 1, 2010
Dear Mr. Zoletti:
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 misJeading.
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 - Mr. Robert Zoletti
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/ucm 1 1 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, plcasc 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. Millman
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 (if known): K090845
Device Name: Apex ARC™ Hip Stem
Indications For Use:
The Apex ARC 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
AND/OR
(Per 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anta for mxn
(Dision Sien-Off) Division of Surgical, Orthopedic, and Resprative Devices
510(k) Number K900845
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