(129 days)
The OMNI ARC Monoblock 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 (Coball 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; .
- י Revision procedures where other treatments or devices have failed;
- . Femoral neck and trochanteric fractures of the proximal femur.
The OMNI ARC Monoblock Hip Stem is also intended for use in hemiathroplasty 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.
The OMNI ARC Monoblock Hip Stem consists of a curved, rectangular tapered stem that combines the neck and stem into a single piece design. The OMNI ARC Monoblock 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 OMNI ARC™ Monoblock 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.
The provided text focuses on the 510(k) summary for the OMNI ARC Monoblock Hip Stem, primarily establishing substantial equivalence to predicate devices through material similarity and performance testing. It does not contain the detailed setup and results of a clinical study or a study involving human readers and AI assistance for diagnostic accuracy. Therefore, many of the requested sections regarding acceptance criteria and study particulars cannot be filled using the provided information.
However, based on the provided text, we can infer some "acceptance criteria" related to mechanical performance and report the device's stated performance in those areas.
Here's an attempt to answer your questions based solely on the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from testing performed) | Reported Device Performance (OMNI ARC Monoblock Hip Stem) |
|---|---|
| Fatigue strength per ISO 7206-6 | Met the requirements |
| Fatigue strength per ISO 7206-4 | Met the requirements |
| Range-of-motion requirement per ISO 21535 | Met the requirements |
| Material composition | Titanium alloy, unalloyed titanium plasma spray, with hydroxyapatite coating (identical to predicate devices) |
2. Sample size used for the test set and the data provenance
The document describes mechanical testing of the device components, not a clinical test set with patient data. Therefore, this question is not applicable to the information provided. The study mentioned is primarily an engineering performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as the document describes mechanical testing, not a study requiring expert clinical interpretation for ground truth.
4. Adjudication method for the test set
This question is not applicable as the document describes mechanical testing, not a study requiring adjudication of clinical findings.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No such MRMC study is mentioned in the provided 510(k) summary. The document describes mechanical performance testing of a hip stem, not a diagnostic AI device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The device is a physical hip stem, not an algorithm.
7. The type of ground truth used
For the mechanical tests, the "ground truth" would be the specifications and requirements defined by the ISO standards (ISO 7206-6, ISO 7206-4, ISO 21535). The device's performance was compared directly against these established engineering standards.
8. The sample size for the training set
This question is not applicable as the device is a physical medical implant, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
This question is not applicable.
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| 510(K) SUMMARY | |
|---|---|
| Date Summary Prepared | November 1, 2013 |
| Manufacturer/Distributor/Sponsor | OMNIlife Science50 O'Connell WaySuite 10East Taunton, MA 02718 |
| 510(k) Contact | Christina FloresManager, Regulatory AffairsOmnilife Science50 O'Connell WayEast Taunton, MA 02718Telephone: 774-226-1835Fax: 508-822-6030Email: cflores@omnils.com |
| Trade Name | OMNI ARC Monoblock Hip Stem |
| Common Name | prosthesis, hip, semi-constrained,metal/polymer, porous uncementedprosthesis, hip, semi-constrained, uncemented,metal/polymer, non-porous, calcium-phosphate |
| Classification Name | 21 CFR 888.3353 Hip jointmetal/ceramic/polymer semi-constrainedcemented or nonporous uncementedprosthesis. LZO, MEH, LPH, KWY |
| Predicate Device | K113242 - Apex Hip System ARCTM Hip Stem(cleared size 0)K110947 - Apex K1TM Hip StemReference predicates:K111193 Apex Hip System ARCTM Hip Stem(cleared size 1-5)K060072 Apex K1 Hip Stem(cleared size 2-12) |
| Purpose of Submission | This Traditional 510(k) premarket notification isbeing submitted to obtain clearance for theOMNI ARC Monoblock Hip Stem to expandOMNI's product offering for total hiparthroplasty. |
| 510(K) SUMMARY | |
| Device Description and intended use | The OMNI ARC Monoblock Hip Stem consists of a curved, rectangular tapered stem that combines the neck and stem into a single piece design. The OMNI ARC Monoblock 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 OMNI ARC™ Monoblock 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. |
| 510(K) SUMMARY | |
| Substantial Equivalence Summary | The OMNI ARC Monoblock Hip Stem issubstantially equivalent to the predicate APEXARC Hip Stem (K113242) and the Apex K1 HipStem (K110947) in which the fundamentalscientific technology and intended uses are thesame. Any differences between the OMNI ARCMonoblock Hip Stem and the predicates areconsidered minor and do not raise questionsconcerning safety and effectiveness.The proposed devices are composed oftitanium alloy, unalloyed titanium plasma spray,with hydroxyapatite coating, the identicalmaterial used in the manufacture of thepredicate devices.The results of testing of the proposed ARCMonoblock Hip Stems met the requirements forfatigue strength per ISO 7206-6 and ISO 7206-4 and the range-of-motion requirement per ISO21535. These test methods are the same usedfor the predicate devices (K110947 andK113242). Based on the indications for use,technological characteristics, and thecomparison to the predicate devices, OMNIlifeScience has determined that the OMNI ARCMonoblock Hip Stem is substantially equivalentto currently marketed predicate devices. |
K133381 Al Response March 7, 2014
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 13, 2014
OMNIlife Science Ms. Christina Flores Manager, Regulatory Affairs 50 O'Connell Way, Suite 10 East Taunton, Massachusetts 02718
Re: K133381
Trade/Device Name: OMNI ARC Monoblock Hip Stem Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO, MEH, LPH, KWY Dated: February 6, 2014 Received: February 10, 2014
Dear Ms. Flores:
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
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Page 2 - Ms. Christina Flores
(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 (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 vours.
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): Not Known K1 3 3 3 8 1
Device Name: OMNI ARC Monoblock Hip Stem
The OMNI ARC Monoblock 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 (Coball 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; .
- י Revision procedures where other treatments or devices have failed;
- . Femoral neck and trochanteric fractures of the proximal femur.
The OMNI ARC Monoblock Hip Stem is also intended for use in hemiathroplasty 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 Prescription Use X (Part 21 CFR 801 Subpart D)
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)
RC Monoblock Hip Stem
Page 15 of 172
§ 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.