(54 days)
No
The device description and intended use are purely mechanical, describing a physical implant made of porous titanium. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are non-clinical laboratory tests, not studies involving data analysis or image processing.
Yes.
The device is indicated for conditions such as osteoarthritis, avascular necrosis, rheumatoid arthritis, correction of functional deformity, and treatment of fractures, all of which aim to treat or alleviate a disease or injury.
No
This device is an implantable medical device (acetabular augment) used in orthopedic surgery to treat certain conditions and revise failed hip arthroplasties; it does not diagnose medical conditions.
No
The device description clearly states it is constructed of porous titanium alloy and describes physical dimensions and features like screw holes, indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Porous Titanium Acetabular Augments are implants designed to be surgically placed in the hip joint to address bone deficiencies during hip replacement or revision surgery. They are a physical component used in a surgical procedure, not a tool for analyzing biological samples.
- Intended Use: The intended use clearly describes their role in treating specific orthopedic conditions and providing structural support in the acetabulum. This is a therapeutic and reconstructive function, not a diagnostic one.
The provided information consistently describes a surgical implant, not a device used for in vitro testing.
N/A
Intended Use / Indications for Use
The Porous Titanium Acetabular Augments are indicated for cemented or non-cemented use in cases of:
- 1 . Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis.
-
- Correction of functional deformity.
-
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
-
- Revision of previously failed total hip arthroplasty.
The porous titanium augments are intended to provide the orthopedic surgeon with a prosthetic alternative to structural allograft in cases of segmental deficiencies.
The porous titanium acetabular augment is affixed to the mating acetabular cup using bone cement. The assembled porous titanium augment/acetabular construct is intended for cemented or uncemented use.
The porous titanium acetabular augments are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery.
Product codes
KWA, JDI, JDL, KWZ, LPH, LZO, MAY, MEH
Device Description
The acetabular augments are constructed of porous titanium alloy conforming to ASTM F 1580-95. The augments range in outer diameter size from 48 mm to 58 mm in 2 mm increments. Each outer diameter will have three subsizes; small, medium, and large. The Porous Titanium Acetabular Augments incorporate screw holes that allow for the use of 6.5 mm bone screws, for adjunct fixation of the acetabular component and the native bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, proximal femur
Indicated Patient Age Range
skeletally mature individuals
Intended User / Care Setting
orthopedic surgeon
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 to determine substantial equivalence. The results indicated that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
K05>888 pgx '14
DEC 6 2005
510(k) Summary
Applicant/Sponsor: Biomet Manufacturing Corp.
Allison Koskey Contact Person:
Proprietary Name: Porous Titanium Acetabular Augments
Common Name: Acetabular augments
Classification Name: Prosthesis, Hip, Semi-constrained, Metal/Polymer, Porous Uncemented (888.3358); Prosthesis, Hip, Semi-constrained, Metal/Polymer, Cemented (888.3350); Hip joint metal/polymer constrained cemented or uncemented prosthesis (888.3310); Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis (888.3320); Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis (888.3330); Hip joint metal/ceramic/polymer semi-constrained cemented or non porous uncemented prosthesis (888.3353)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Hedrocel® Acetabular Augment (K001471)
Device Description: The acetabular augments are constructed of porous titanium alloy conforming to ASTM F 1580-95. The augments range in outer diameter size from 48 mm to 58 mm in 2 mm increments. Each outer diameter will have three subsizes; small, medium, and large. The Porous Titanium Acetabular Augments incorporate screw holes that allow for the use of 6.5 mm bone screws, for adjunct fixation of the acetabular component and the native bone.
Intended Use: The Porous Titanium Acetabular Augments are indicated for cemented or non-cemented use in cases of:
-
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis.
-
- Correction of functional deformity.
-
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
-
- Revision of previously failed total hip arthroplasty.
1
page 2 of 2
The porous titanium augments are intended to provide the orthopedic surgeon with a prosthetic alternative to structural allograft in cases of segmental deficiencies.
The porous titanium acetabular augment is affixed to the mating acetabular cup using bone cement. The assembled porous titanium augment/acetabular construct is intended for cemented or uncemented use.
The porous titanium acetabular augments are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery.
Summary of Technologies: The technological characteristics (material modification, design, sizing, indications) of the Porous Titanium Acetabular Augments are similar to or identical to the predicate device.
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are property of Biomet, Inc. except for Hedrocel®, which is property of Zimmer Holdings
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with outstretched arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 6 2005
Allison Koskey Regulatory Specialist Biomet Manufacturing Corp. P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K052888
K052860
Trade/Device Name: Porous Titanium Acetabular Augments Regulation Number: 21 CFR 888.3320 Regulation Name: Hip joint metal/metal semi-constrained, with a cemented acetabular component, prostheses Regulatory Class: III Regulatory Class: In
Product Codes: KWA, JDI, JDL, KWZ, LPH, LZO, MAY, MEH Dated: October 10, 2005 Received: October 13, 2005
Dear Ms. Koskey:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section > IQ(x) prematic is substantially equivalent (for the indications
referenced above and have determined the device is substanted in interstate referenced above and nave delemined the active are devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate device Amendments for use stated in the enclosure) to regally manced producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food. Drug commerce prior to May 28, 1970, the chaculence with the provisions of the Federal Food. Drug, devices that have been reciassified in accordance whiles approval application (IPMA).
and Cosmetic Act (Act) that do not require approval as provisions of the Act . The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The Act. The Act. The You may, therefore, market the device, subject to tire genirements for annual registration, listing of
general controls provisions of the Act include requirements for and general controls provisions of the receiners required required in the branding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it can If your device is classified (see above) mis existing major regulations affecting your device can
may be subject to such additional controls. Time A. B.A. In oddition FTA m may be subject to such additional controlist Existing major osyon to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 Register be found in the Code of Federal Regarations, our device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuales of a substition on the requirements of the Act
that FDA has made a determination that your device coderal groppies. You must that FDA has made a determination inal your areas by other Federal agencies. You must or any Federal statutes and regilantons annimaling, but limited to: registration and listing (21
comply with all the Act's requirements, including, but him and isats as set comply with all the Act S requirements, merasms, manufacturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); end if emplicable, the electronic CFR Part 807); labeling (21 CFR Fall on (21 CFR Part 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Pat 820); and if applicable, forth in the quanty systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1
3
Page 2- Allison Koskey
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin makemig your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivales and thus, per premarket notification. The PDA intuing of substanted by and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
r the recultive and the same of the said to the regulation entitled If you desire specific advice for your ac 110 concerner and and the regulation entitled. contact the Office of Compliance at (301) 99 - 100.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Partha Division of Small "Misbranding by reference to premants noufficalson of Sct from the Division of Small other general information on your responsion.com its toll-free number (800) 638-2041 or 2010)
Manufacturers, International and Consumer Assistance of Virginator viruspotvinde Manufacturers, International and Consumer > Ibolicanoo a rovedrh/industry/suppoty/index.html.
Sincerely yours,
2
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Porous Titanium Acetabular Augments
Indications For Use:
The Porous Titanium Acetabular Augments are indicated for cemented or non-cemented use in cases of:
- 1 . Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis.
-
- Correction of functional deformity.
-
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
-
- Revision of previously failed total hip arthroplasty.
The porous titanium augments are intended to provide the orthopedic surgeon with a prosthetic alternative to structural allograft in cases of segmental deficiencies.
The porous titanium acetabular augment is affixed to the mating acetabular cup using bone cement. The assembled porous titanium augment/acetabular construct is intended for cemented or uncemented use.
The porous titanium acetabular augments are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery.
× Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
AND/OR (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Q.83
(Division Sign-Off) Division of Ceneral, Rostorative,
Page 1 of 1
and Neurological Devices
510(k) Number K052889