(63 days)
Not Found
No
The document describes a mechanical hip implant and its intended use, materials, and testing. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
This device is a hip stem for total hip arthroplasty, which is a surgical procedure to alleviate pain and restore function in the hip joint. This clearly indicates a therapeutic purpose.
No
Explanation: The device is a monolithic femoral hip prosthesis (hip stem), intended for use in total hip arthroplasty procedures to alleviate pain and restore function. It is an implantable medical device, not a diagnostic tool.
No
The device description clearly describes a physical, monolithic femoral hip prosthesis made of TMZF alloy with a hydroxylapatite coating, intended for surgical implantation. This is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The device described is a femoral hip prosthesis, which is an implantable medical device used in surgery to replace a damaged hip joint.
- Intended Use: The intended use is for total hip arthroplasty, a surgical procedure.
- No mention of biological samples: The description and intended use do not involve the analysis of any biological samples from the patient.
Therefore, this device falls under the category of a surgical implant, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The indications for use for total hip arthroplasty include:
- noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- rheumatoid arthritis;
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and,
- nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Additional indication specific to use of ABG™ II Monolithic Hip Stem with compatible Howmedica Osteonics Constrained Liners:
- When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intraoperative instability.
The Stem is intended for cementless, press-fit use only and is intended for total and hemiarthroplasty procedures'.
Product codes (comma separated list FDA assigned to the subject device)
MAY, LZO, MEH, LPH, MBL
Device Description
Howmedica Osteonics is introducing a monolithic femoral hip prosthesis. The basic design of the ABG™ II Monolithic Hip Stem, referred as the ABG™ II, is similar to other total hip systems commercially distributed such as the Stryker ABG™ II Modular Hip System.
The subject hip stem is a TMZF (Ti-11.5 Mo-6Zr-2Fe) alloy femoral stem with a roughened hydroxylapatite coating in the proximal region. It is intended for cementless, press-fit application and designed for use with the currently available compatible Howmedica Osteonics' femoral heads, bipolar heads, and their compatible acetabular components.
The ABGTM II Monolithic Hip Stem is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. The stem is designed for use with the currently available compatible Howmedica Osteonics' femoral heads and their compatible acetabular components. Head compatibility with the stems includes: V40 Biolox Delta, Biolox Delta Universal Taper Heads and Sleeves, V40 CoCr Heads, V40 LFIT CoCr Heads, C-Taper Alumina Heads when used with the V40/C-taper Adaptor, C-Taper Delta Heads when used with C-taper Adaptor, UHR Universal Head, Unitrax Heads when used with the Unitrax V40 Modular Adapter.
The ABGTM II Monolithic Hip Stem will be available in 8 sizes ranging from size 1 through 8 with one neck angle of 130°. The ABG™ II Monolithic Hip Stem anatomic stem is made with 12° of anteversion built into the proximal portion of the stem.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
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 Testing: Non-clinical laboratory testing was performed for the hip stem to determine substantial equivalence. Non-clinical testing was provided as outlined in the FDA Guidance Document entitled "Non-clinical Information for Femoral Stem Prostheses (17 September 2007)". Femoral neck fatigues testing and distal stem fatigues testing were conducted on the worst-case sizes determined by Finite Element Analysis. The testing demonstrated that the ABG ™ II Monolithic Hip Stem is substantially equivalent to devices currently cleared for marketing.
Clinical Testing: Clinical testing was not required for this submission.
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
§ 888.3353 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
510(k) Summary of Safety and Effectiveness
MAY 2 5 2011
| Sponsor | Howmedica Osteonics Corp. |
|---|---|
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Contact Person | Stephanie Fitts |
| Sr. Director, Regulatory Affairs & Regulatory Compliance | |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Phone: (201) 831-5405 | |
| Date Prepared: | March 21, 2011 |
| Proprietary Name: | ABG ™ II Monolithic Hip Stem |
| Common Name: | Hip prosthesis |
| Classification Name: | Hip joint metal/ceramic/polymer semi-constrained cemented or |
| nonporous uncemented prosthesis, 21 CFR §888.3353 (Product | |
| Codes MAY, LZO, MEH) | |
| Hip joint metal/polymer/metal semi-constrained porous coated | |
| uncemented prosthesis, 21 CFR §888.3358 (Product Codes LPH, | |
| MBL) |
Legally Marketed Device to Which Substantial Equivalence is Claimed: ABG TM II Modular Hip Stem K092406.
Device Description:
Howmedica Osteonics is introducing a monolithic femoral hip prosthesis. The basic design of the ABG™ II Monolithic Hip Stem, referred as the ABG™ II, is similar to other total hip systems commercially distributed such as the Stryker ABG™ II Modular Hip System.
The subject hip stem is a TMZF (Ti-11.5 Mo-6Zr-2Fe) alloy femoral stem with a roughened hydroxylapatite coating in the proximal region. It is intended for cementless, press-fit application and designed for use with the currently available compatible Howmedica Osteonics' femoral heads, bipolar heads, and their compatible acetabular components.
The ABGTM II Monolithic Hip Stem is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. The stem is designed for use with the currently available compatible Howmedica Osteonics' femoral heads and their compatible acetabular components. Head compatibility with the stems includes: V40 Biolox Delta, Biolox Delta Universal Taper Heads and Sleeves, V40 CoCr Heads, V40 LFIT CoCr Heads, C-Taper Alumina Heads when used with the V40/C-taper Adaptor, C-Taper Delta Heads when used with C-taper Adaptor, UHR Universal Head, Unitrax Heads when used with the Unitrax V40 Modular Adapter.
1
The ABGTM II Monolithic Hip Stem will be available in 8 sizes ranging from size 1 through 8 with one neck angle of 130°. The ABG™ II Monolithic Hip Stem anatomic stem is made with 12° of anteversion built into the proximal portion of the stem.
Indications:
The indications for use for total hip arthroplasty include:
- t noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- 프 rheumatoid arthritis;
- correction of functional deformity;
- .. revision procedures where other treatments or devices have failed; and,
- . nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Additional indication specific to use of ABG™ II Monolithic Hip Stem with compatible Howmedica Osteonics Constrained Liners:
- · When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intraoperative instability.
The Stem is intended for cementless, press-fit use only and is intended for total and hemiarthroplasty procedures'.
Summary of Technologies: Device comparison showed that the proposed device is substantially equivalent in intended, use, materials and performance characteristics to the predicate device.
Non-Clinical Testing: Non-clinical laboratory testing was performed for the hip stem to determine substantial equivalence. Non-clinical testing was provided as outlined in the FDA Guidance Document entitled "Non-clinical Information for Femoral Stem Prostheses (17 September 2007)". Femoral neck fatigues testing and distal stem fatigues testing were conducted on the worst-case sizes determined by Finite Element Analysis. The testing demonstrated that the ABG ™ II Monolithic Hip Stem is substantially equivalent to devices currently cleared for marketing.
Clinical Testing: Clinical testing was not required for this submission.
Conclusion: The ABG ™ II Monolithic Hip Stem is substantially equivalent to the predicate devices identified in this premarket notification.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the staff and a winding shape representing the snakes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Howmedica Osteonics Corp. % Dr. Stephanie Fitts 325 Corporate Drive Mahwah, NJ 07430
MAY 25 2011
Re: K110807
Trade/Device Name: ABG™ II Monolithic Total Hip Stem Regulation Number: 21 CFR §888.3353; 21 CFR §888.3358 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis; Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis Regulatory Class: II Product Code: MAY, LZO, MEH; LPH, MBL Dated: March 21, 2010 Received: March 23, 2010
Dear Dr. Fitts.
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
3
Page 2 - Dr. Stephanie Fitts
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. 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.
http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm
Sincerely yours,
Mark A. Milleson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices _Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4: Indications for Use Statement
510(k) Number (if known):
Device Name: ABGTM II Monolithic Hip Stem
The indications for use for total hip arthroplasty include:
noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis:
rheumatoid arthritis:
correction of functional deformity;
revision procedures where other treatments or devices have failed; and.
nonunions, femoral neck fractures, and trochanteric fractures of the proximal
femur with head involvement that are unmanageable using other techniques.
Additional indication specific to use of ABG™II Monolithic Hip Stem with compatible Howmedica Osteonics Constrained Liners:
When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.
Stryker's ABG™ II Monolithic Hip Stem is intended for cementless use only and is intended for total and hemi-arthroplasty procedures.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use ----------AND/OR (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (Of
Mark A. Miller
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110807