(77 days)
Not Found
No
The 510(k) summary describes a mechanical hip stem and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is a hip prosthesis, which is used to replace a damaged hip joint and provide increased patient mobility and reduce pain, thereby treating a medical condition.
No
The device described is a hip stem (prosthesis), which is an implant used for total hip arthroplasty to replace a damaged hip joint. Its purpose is therapeutic, not diagnostic.
No
The device description clearly states the device is a "collarless, titanium, tapered femoral stem" with a "sintered commercially pure bead porous coating" and "hydroxyapatite (HA) coating." This describes a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing a damaged hip joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant (a hip stem) made of titanium with coatings. This is consistent with a surgical device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:
- Severely painful and/or disabled joint from 1. osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head. 2.
- Acute traumatic fracture of the femoral head 3. or neck.
- Failed previous hip surgery including joint র্বা reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthro-plasty, or total hip replacement.
- Certain cases of ankylosis.
The Summit Duofix™ Hip Stem is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating.
Product codes (comma separated list FDA assigned to the subject device)
87LPH, MEH
Device Description
The Summit DuoFix™ Porous Hip prosthesis is a collarless, titanium, tapered femoral stem. The hip stem is manufactured from titanium (Ti-6Al-4V) and has a sintered commercially pure bead porous coating (Porcoat®) titanium applied to the stem with a thin layer of hydroxyapatite (HA) coating applied. The hip stem consists of 10 body sizes ranging in diameter from 7mm (Size 1) to 18mm (Size 10) with each body size having two offset options.
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)
Not Found
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
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
JUL 3 1 2001
Image /page/0/Picture/1 description: The image shows the DePuy logo, which is a black circle followed by the word "DePuy" in a stylized font. Below the word "DePuy" is the text "a Johnson & Johnson company" in a smaller font. At the top of the image is the number K011489.
510(k) Summary
DePuy Orthopaedics, Inc
700 Orthopaedic Drive 0 Box 988 Warsaw, Indiana 46581-0988 USA
Name of Sponsor:
510(k) Contact:
Trade Name:
Common Name:
Classification:
Device Product Code:
Substantially Equivalent Device:
Device Descriptions:
Marcia J. Arentz Senior Regulatory Associate Phone: (219) 371-4944 FAX: (219) 371-4940
DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Est. Reg. No. 1818910
Summit™ DuoFix™ Hip Prosthesis
Total Hip Joint Replacement Prosthesis with porous coating
700 Orthopaedic Drive
Class II Device per 21 CFR 888.3358: Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis
Code: 87LPH Prosthesis Hip Semi-constrained, Metal/Polymer, Porous Uncemented No performance standards have been established under Section 514 of the Federal Food, Drug, and Cosmetic Act for femoral hip stems.
Hip Stem K001991 DePuy Titan Porocoat Hip Stem Zimmer HGP Hip with HA/TCP coating K980711 HA/Porous Coating K001277 DePuy TriFlange Acetabular Cup
The Summit DuoFix™ Porous Hip prosthesis is a collarless, titanium, tapered femoral stem. The hip stem is manufactured from titanium (Ti-6Al-4V) and has a sintered commercially pure bead porous coating (Porocoat®) titanium applied to the stem with a thin layer of hydroxyapatite (HA) coating applied. The hip stem consists of 10 body sizes ranging in diameter from 7mm (Size 1) to 18mm (Size 10) with each body size having two offset options.
1
510(k) Summary (continued)
Intended use:
Indications for use:
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
Total hip replacement is indicated in the following conditions:
- Severely painful and/or disabled joint from 1. osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head. 2.
- Acute traumatic fracture of the femoral head 3. or neck.
- Failed previous hip surgery including joint র্বা reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthro-plasty, or total hip replacement.
- ર. Certain cases of ankylosis.
The Summit Duofix™ Hip Stem is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating.
Substantial equivalence:
The Summit™ DuoFix™ Hip Prosthesis has the same intended use, is made from similar materials and has the same basic design as the predicate devices and is therefore substantially equivalent.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them. The logo is black and white.
JUL 3 1 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Marcia J. Arentz Senior Regulatory Associate DePuy Orthopaedics, Inc. 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 46581-0988
Re: K011489
Device Name: Summit DuoFix Hip Prosthesis Regulation Number: 21 CFR 888.3358 Regulatory Class: II Product Codes: LPH, MEH Dated: May 14, 2001 Received: May 15, 2001
Dear Ms. Arentz:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have teviewed your becaon 31 (x).) health and stantially equivalent (for the indications for use above and we nave dolorimined the actested predicate devices marketed in interstate commerce stated in the enclosure) to logally mazione of the Medical Device Amendments, or to devices that prox to May 20, 1970, the chiculation with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (Act). "Tou may, alercrors, and the Act include requirements for annual provisions of the ret. "The general conanufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations (Fremarkst Approval), it may of sacreer of Sales of Federal Regulations, Title 21, Parts 800 to 895. alloomig your determination assumes compliance with the Current Good A substantially Oqurvaters as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mspections, the Food and Drug rainingsult in regulatory action. In addition, FDA may publish comply with the GMI regarations your device in the Federal Register. Please note: this response to your premarks beforeming you submission does not affect any obligation you might response to your premariter associated of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed
3
Page 2 - Ms. Marcia J. Arentz
predicate device results in a classification for your device 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Mmhluudr for
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): _ Kol 1489)
Device Name: Summit™ DuoFix™ Hip Prosthesis
Indications for Use:
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:
-
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head. 2.
-
- Acute traumatic fracture of the femoral head or neck.
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, 4. hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis. న్.
The Summit Duofix™ Hip Stem is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating.
Concurrence of CDRH, Office of Device Evaluation
Bmotthellorpr can
(Division Sign-Off) Division of General, Restorative Over-The-Count Neurological Devices
510(k) Number KD 11489
OR Prescription Use (Per 21 CFR 801.109)
000003