(28 days)
No
The device description focuses on material properties, size extension, and mechanical testing, with no mention of AI or ML.
Yes
The device is a component of a total hip arthroplasty, which is a procedure to treat painful and disabling joint disease of the hip, correct functional deformities, and treat certain fractures, all of which are therapeutic interventions.
No
The device is a ceramic femoral head designed for total hip arthroplasty, serving as a replacement or component in surgical procedures. It does not perform any diagnostic functions like disease detection or assessment.
No
The device description clearly describes a physical implantable medical device (a ceramic femoral head) and its associated hardware components (cups and stems). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for use in total hip arthroplasty for treating various painful and disabling hip conditions. This is a surgical procedure involving the replacement of a joint.
- Device Description: The description details a femoral head, which is a component of a hip implant. It describes its material, size, and how it articulates with other implant components.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is implanted in vivo (inside the body) and is a physical component for joint replacement.
Therefore, this device is a surgical implant and not an IVD.
N/A
Intended Use / Indications for Use
"UNITED" 36 mm Ceramic Femoral Head - Delta is indicated for use in total hip arthroplasty for the following conditions: painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis; correction of functional deformity; treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques; revision procedures where other treatment or devices have failed arthroplasty or other procedure.
Product codes (comma separated list FDA assigned to the subject device)
LZO, MEH, LPH
Device Description
"UNITED" 36 mm Ceramic Femoral Head - Delta is an additional size extension to the previously cleared "UNITED" Ceramic Femoral Head (K103497). The materials, design, safety and effectiveness of this subject are identical to the previously cleared Ceramic Femoral Head - Delta Components (available in sizes 28 mm and 32 mm), except for its larger diameter (available in sizes 36 mm). 36 mm Ceramic Femoral Head - Delta manufactured from zirconia-toughened alumina ceramic is available in -3, +1, +5 and +9 mm of neck length. This device is intended to articulate against XPE cup liners (K111546) and can be used in conjunction with U2 Acetabular Cups and U2 Hip Stem made of titanium. U2 Acetabular Cups include U2 HA/Ti Plasma Spray Cup (K050262). U2 Ti Plasma Spray Cup (K050262) and U2 Ti Porous Cup (K111546), while U2 Hip Stem include HA/Ti Plasma Spray Stem (K003237), Ti Porous Coated Stem (K003237), Ti Plasma Spray Revision Stem (K062978), Ti Press-fit Stem (K111546) and UTF Stem (K110245). The size extension does not affect the intended use of the device or alter the fundamental scientific technology of the device.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
This 510(k) was prepared in accordance with "Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems". Burst test, fatigue test, burst test for post-fatigue, rotational resistance test and pull-off test. completed as part of the design assurance process demonstrated that this device is safe and effective and is substantially equivalent to the predicate device.
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.
K103497, K083762, K100412, K042091, K061312, K051411
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.
K111546, K050262, K003237, K062978, K110245
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
K112463*"1/3
(0) 36 mm Ceramic Femoral Head, Delta: Special 510 (K)
510(k) Summary
510(k) Summary of Safety and Effectiveness
| Submitted by: | United Orthopedic Corporation |
|---|---|
| Address: | No 57, Park Ave 2, Science Park, Hsinchu 300, Taiwan |
| Phone Number: | +886-3-5773351 ext. 212 |
| Fax Number: | +886-3-577156 |
| Date of Summary: | August 25, 2011 |
| Contact Person | Fang-Yuan Ho |
| Regulation and Document Management | |
| Proprietary Name: | 36 mm Ceramic Femoral Head, Delta |
| Common Name: | Semi-constrained total hip prostheses |
| Device Classification | Hip joint metal/ceramic/polymer semi-constrained cemented |
| or nonporous uncemented prosthesis under 21CFR 888.3353 | |
| This falls under the Orthopedics panel. | |
| Device Class | Class II |
| Panel Code | Orthopaedics Device |
| Device Product Code: | LZO, MEH, LPH |
| Predicate Device: | 1. "UNITED" Ceramic Femoral Head, manufactured by |
| United Orthopedic Corporation, K103497, cleared March | |
| 04, 2011 |
- Smith & Nephew BIOLOX® Delta Ceramic Femoral
Heads (K083762, K100412) - BIOMET BIOLOX® Delta Ceramic Heads (K042091,
K061312, K051411) |
Device Description:
"UNITED" 36 mm Ceramic Femoral Head – Delta is an additional size extension to the
Page: Summary-1/3
1
(0) 36 mm Ceramic Femoral Head, Delta: Special 510 (K) 510(k) Summary
previously cleared "UNITED" Ceramic Femoral Head (K103497). The materials, design, safety and effectiveness of this subject are identical to the previously cleared Ceramic Femoral Head - Delta Components (available in sizes 28 mm and 32 mm), except for its larger diameter (available in sizes 36 mm). 36 mm Ceramic Femoral Head - Delta manufactured from zirconia-toughened alumina ceramic is available in -3, +1, +5 and +9 mm of neck length. This device is intended to articulate against XPE cup liners (K111546) and can be used in conjunction with U2 Acetabular Cups and U2 Hip Stem made of titanium. U2 Acetabular Cups include U2 HA/Ti Plasma Spray Cup (K050262). U2 Ti Plasma Spray Cup (K050262) and U2 Ti Porous Cup (K111546), while U2 Hip Stem include HA/Ti Plasma Spray Stem (K003237), Ti Porous Coated Stem (K003237), Ti Plasma Spray Revision Stem (K062978), Ti Press-fit Stem (K111546) and UTF Stem (K110245). The size extension does not affect the intended use of the device or alter the fundamental scientific technology of the device.
Intended Use
"UNITED" 36 mm Ceramic Femoral Head - Delta is indicated for use in total hip arthroplasty for the following conditions: painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis; correction of functional deformity; treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques; revision procedures where other treatment or devices have failed arthroplasty or other procedure.
Basis for Substantial Equivalence:
The safety and effectiveness of 36 mm Ceramic Femoral Head - Delta are substantially Page: Summary-2/3 UOC-FDA-019
2
(0) 36 mm Ceramic Femoral Head, Delta: Special 510 (K) 510(k) Summary
equivalent to the previously cleared Ceramic Femoral Head (K103497), except for an extension in the size distribution. The modifications do not change the intended use or fundamental scientific technology. In addition, the subject device is also substantial equivalence to the Smith & Nephew BIOLOX® Delta Ceramic Femoral Heads (K083762, K100412) and BIOMET BIOLOX® Delta Ceramic Heads (K042091, K061312, K051411).
Performance Data:
This 510(k) was prepared in accordance with "Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems". Burst test, fatigue test, burst test for post-fatigue, rotational resistance test and pull-off test. completed as part of the design assurance process demonstrated that this device is safe and effective and is substantially equivalent to the predicate device.
3
Image /page/3/Picture/1 description: The image shows a circular logo with an abstract bird design in the center. The bird is composed of three curved lines that suggest movement or flight. Encircling the bird is text, which appears to be part of the logo's name or a related phrase. The overall design is simple and symbolic, likely representing a company or organization associated with aviation, nature, or a similar field.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MI) 20993-0002
United Orthopedic Corporation % Fang-Yuan Ho Regulatory Affairs Manager 57 park Ave. 2, Sience Park Hsinchu, China (Taiwan) 300
SEP 23 2011
Re: K112463 Trade/Device Name: 36mm Ceramic Femora Head, Delta 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 Dated: August 16. 2011 Received: August 26, 2011
Dear Fang-Yuan Ho:
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 (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 - Fang-Yuan Ho
forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 331-542 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.
Sincerely yours.
E.O. Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indication for Use
510 (k) Number (if known): مالاس2 (if known): 510)
Device Name: 36 mm Ceramic Femoral Head, Delta
Indications for Use:
This device is indicated for use in total hip arthroplasty for the following conditions: painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis; correction of functional deformity; treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques; revision procedures where other treatment or devices have failed arthroplasty or other procedure.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
.
AND/OR
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)
Michael Owens for mxm
gical, Orthopedic, Restorative Devic
Page 1 of l
510(k) Number K112463