(27 days)
No
The summary describes a mechanical hip implant system and its materials, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is intended to treat severe hip pain and disability due to various medical conditions, indicating a therapeutic purpose.
No
Explanation: The Excia Hip System is a surgical implant intended to replace a hip joint, not to diagnose a condition.
No
The device description explicitly states the device is a femoral stem manufactured from CoCrMo or Ti, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "replace a hip joint" in patients with various hip conditions. This is a surgical implant, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a femoral stem, which is a component of a hip replacement implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's condition based on laboratory testing.
The device is clearly a medical device intended for surgical implantation to treat a physical condition.
N/A
Intended Use / Indications for Use
The Excia Hip System is intended to replace a hip joint.
The device is intended for:
· Patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur
· Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral ephiphysis
- · Patients suffering from disability due to previous fusion
- · Patients with acute femoral neck fractures
The Excia Hip System is available with two (2) femoral stems. One is manufactured from CoCr and intended for cemented fixation. The other femoral stem is for uncemented fixation and manufactured from Ti with Plasmapore with or without uCaP®.
Product codes
LZO, LWJ, KWY
Device Description
Excia T cemented femoral stem is manufactured from CoCrMo. The femoral stem will be offered in a 12/14 taper in stem sizes 10 to 20. The stems are designed without a trochanter wing and features a shorter stem length with an asymmetrical distal tip.
Excia T femoral stem is intended for cemented use.
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
Endurance properties of the Excia T cemented stem, head and neck were evaluated in accordance to Guidance for Industry and FDA Staff Non-clinical Information for Femoral Prostheses, September 17, 2007; ASTM F2068-09; ISO 7206-4 and ISO 7206-6. Testing demonstrated that the subject device is substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K140915, K042344, K060437, K060918, K061344, K092143
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.
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Image /page/0/Picture/1 description: The image contains the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of an eagle or bird with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
February 9, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Aesculap Implant Systems, LLC Ms. Julie Tom Wing Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K150062 Trade/Device Name: Excia Total Hip System 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, LWJ, KWY Dated: January 12, 2015 Received: January 13, 2015
Dear Ms. Wing:
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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(21 CFR Part 807); labeling (21 CFR Part 801); medical device 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150062
Device Name Excia Total Hip System
Indications for Use (Describe) The Excia Hip System is intended to replace a hip joint.
The device is intended for:
· Patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur · Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral ephiphysis
- · Patients suffering from disability due to previous fusion
- · Patients with acute femoral neck fractures
The Excia Hip System is available with two (2) femoral stems. One is manufactured from CoCr and intended for cemented fixation. The other femoral stem is for uncemented fixation and manufactured from Ti with Plasmapore with or without uCaP®.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Page 1 of 3
B. 510(k) SUMMARY (as required by 21 CFR 807.92)
Excia Total Hip System Excia T Cemented Femoral Stem
January 12, 2015
COMPANY:
Aesculap Implant Systems, LLC 3773 Corporate Parkway Center Valley, PA 18034
Establishment Registration Number: 3005673311
CONTACT:
Julie Tom Wing 610-984-9147 (phone) 610-791-6882 (fax) julie.tomwinq@aesculap.com
TRADE NAME:
Excia Total Hip System
COMMON NAME:
Femoral Hip Stem
CLASSIFICATION NAME(s):
Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis
Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Hip joint femoral (hemi-hip) metal polymer cemented or uncemented prosthesis
REGULATION NUMBER(S): 888.3353; 888.3360; 888.3390
CLASSIFICATION LZO PRODUCT CODE(S):
SUBSEQUENT PRODUCT CODE(S): LWJ: KWY
SUBSTANTIAL EQUIVALENCE
Aesculap Implant Systems, LLC believes that the addition of cemented Excia T femoral stems to Excia Total Hip System is substantially equivalent to Aesculap Implant Systems Excia Total Hip System (510(K)s K140915 and K060918).
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Page 2 of 3
DEVICE DESCRIPTION
Excia T cemented femoral stem is manufactured from CoCrMo. The femoral stem will be offered in a 12/14 taper in stem sizes 10 to 20. The stems are designed without a trochanter wing and features a shorter stem length with an asymmetrical distal tip.
Excia T femoral stem is intended for cemented use.
PURPOSE FOR PREMARKET NOTIFICATION
The purpose of this premarket notification is to qain clearance of Excia T 12/14 cemented femoral stems, a line extension which complements the full product range of offered stems in Aesculap Implant Systems Excia Hip System (510(K)s K140915, K042344, K060437, K060918, and K061344, and K092143).
INDICATIONS FOR USE
The Excia Hip System is intended to replace the hip joint.
The device is intended for:
- Patients suffering from severe hip pain and disability due to rheumatoid arthritis, ● osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur
- Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral ● ephiphysis
- Patients suffering from disability due to previous fusion ●
- Patients with acute femoral neck fractures ●
The Excia Hip System is available with two (2) femoral stems. One is manufactured from CoCr and intended for cemented fixation. The other femoral stem is for uncemented fixation and manufactured from Ti with Plasmapore with or without µCaP®
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Page 3 of 3
TECHNOLOGICAL CHARACTERISTICS (compared to Predicate(s))
The addition of 12/14 Excia T cemented femoral hip stems to Aesculap Excia Hip System is substantially equivalent to the Excia Total Hip System. The subject device has the same technoloqical characteristics through comparison of the currently marketed stem indications for use, design, materials of construction, manufacturing process, and range of sizes offered.
PERFORMANCE DATA
Endurance properties of the Excia T cemented stem, head and neck were evaluated in accordance to Guidance for Industry and FDA Staff Non-clinical Information for Femoral Prostheses, September 17, 2007; ASTM F2068-09; ISO 7206-4 and ISO 7206-6. Testing demonstrated that the subject device is substantially equivalent to the predicate devices.