(90 days)
No
The document describes a mechanical implant (reconstruction ring) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a hip implant, specifically a reconstruction ring, used to repair damaged hips. While it addresses health issues, it is a medical device intended for surgical repair rather than a therapeutic device that delivers therapy or treatment.
No
Explanation: This device is a total hip component and acetabular reinforcement/reconstruction ring, which are implants used in surgical procedures. They are not intended for diagnosing medical conditions but rather for treating them.
No
The device description clearly describes a physical implant (reconstruction ring) made of metal with screw holes and flanges, intended for surgical implantation. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text describes a total hip component and acetabular reinforcement and reconstruction rings. These are implants designed to be surgically placed within the body to replace or support damaged hip joints.
- Lack of Diagnostic Function: The device's purpose is to restore function and stability to the hip joint, not to analyze biological samples for diagnostic purposes.
The device described is a surgical implant used in orthopedic procedures.
N/A
Intended Use / Indications for Use
Total hip components are indicated for individuals undergoing primary or revision surgery where other treatments have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis; or noninflammatory degenerative joint disease such as osteoarthritis; avascular necrosis; disease (NIDJD) of the hip; slipped capital epiphysis; fused hip; fracture of the pelvis and diastrophic dwarfism; old, remote osteomyelitis with an extended drainage-free period, nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip and correction of deformity.
Acetabular reinforcement and reconstruction rings are intended to be used in primary and revision surgeries where the deficiencies of the acetabular roof, anterior or posterior column, medial wall deficiency, and/or protrusion as a result of the indications listed previously. The device is intended for single use.
Product codes (comma separated list FDA assigned to the subject device)
MEH
Device Description
The Contour HA Coated Reconstruction Ring features a partial cup shape, multiple screw holes and three flanges. The reconstruction ring is secured to host bone or graft bone with bone screws. A Reflection All Poly Cup may be cemented in the reconstruction ring with polymethylmethacrylate (PMMA) bone cement.
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)
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.
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
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JUN 1 4 2004
510(K) SUMMARY contour ha coated reconstruction ring
- SUBMITTER'S NAME: SUBMITTER'S ADDRESS: SUBMITTER'S TELEPHONE NUMBER: CONTACT PERSON: DATE SUMMARY PREPARED: TRADE OR PROPRIETARY DEVICE NAME: COMMON OR USUAL NAME: CLASSIFICATION NAME: DEVICE CLASS: PANEL CODE:
Smith & Nephew, Inc., Orthopaedic Division 1450 Brooks Road, Memphis, TN 38116 901-399-6670 John Reabe March 8, 2004 Contour HA Coated Reconstruction Ring Surgical Mesh Surgical Mesh Class II General and Plastic Surgery/79
DEVICE INFORMATION:
INTENDED USE:
Notel boo.
Total hip components are indicated for individuals undergoing primary or revision surgery where Than hip components are indication for in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis; or noninflammatory degenerative joint imaninatory John disease Such as mountations such as osteoarthritis; avascular necrosis; disease (Nibbia) of thritis; slipped capital epiphysis; fused hip; fracture of the pelvis and diastrophic tradination of this , shpped daptial opply , with an extended drainage-free period, nonunion, femoral neck vanure and trochanteric fractures of the proximal femur with head involvement that are fracture and troonantono fractures; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip and correction of deformity.
Acetabular reinforcement and reconstruction rings are intended to be used in primary and revision Acelabular romore mort and reserved as the deficiencies of the acetabular roof, anterior or posterior Surgenes witcre the doctabularin has aresult of the indications listed previously. The device is intended for single use.
DEVICE DESCRIPTION:
The Contour HA Coated Reconstruction Ring features a partial cup shape, multiple screw holes and three flanges. The reconstruction ring is secured to host bone or graft bone with bone screws. A Reflection All Poly Cup may be cemented in the reconstruction ring with polymethylmethacrylate (PMMA) bone cement.
SUBSTANTIAL EQUIVALENCE INFORMATION:
The Contour HA Coated Reconstruction Ring is substantially equivalent to the Smith & Nephew The Oonlour TH Oodtod Rooment Rings (K962541), Osteonics Restoration Acetabular Ring Rencellen Acolubalar Romersonione & K962007). The Contour HA Coated Reconstruction Ring has a HA coating that is substantially equivalent to the HA coating on the Smith & Nephew HA Tinua and Acetabular Components (K922621) and the Smith & Nephew InterFit HA Coated Acetabular Shell (K990666).
SUMMARY OF TECHNOLOGICAL COMPARISON:
The Contour HA Coated Reconstruction Ring is substantially equivalent to the predicate devices I rro our the previous section in terms of material, indications for use and design.
1
Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines, which are likely meant to represent the department's mission of promoting health and well-being. The seal is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 4 2004
John Reabe Smith & Nephew, Inc. 1450 Brooks Road Memphis, Tennessee 38116
Re: K040680
Trade/Device Name: Contour HA Coated Reconstruction Ring Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: MEH Dated: March 10, 2004 Received: March 16, 2004
Dear Mr. Reabe:
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 for association 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, de reco that hat t (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 r ou may) ateres, mains of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
2
Page 2 - John Reabe
This letter will allow you to begin marketing your device as described in your Section 510(k)
The start of the market of a local starticle and worlds of your device to Jegal This letter will anow you to begin marketing your artist equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of thus, premarket notification. The PDA inding of substanted vice 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
rs the regulation and 160 m 160 m the results and are not the rogulation en If you desire specific advice for your act 100 mease note the regulation entitled, the regulation entitled, contact the Office of Complaned at (301) 64 - 17 - 4 - 1 807.97). You may obtain "Misbranding by relerence to premarket notification of Set from the Division of Small
other general information on your responsibilities under the Act from worker (800) 638, other general Information on your responsion.com its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance of Armanian http://www.ain.html Manufacturers, International and Combailers http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C Provost
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
3
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510(k) number (if known): _ K 6 40 (80
Device Name: Contour HA Coated Reconstruction Ring
Indications for Use:
Total hip components are indicated for individuals undergoing primary or revision surgery Total hip components are indicated fore failed in rehabilitating hips damaged as a result of where other treatments of donose nuch as rheumatoid arthritis; or noninflammatory trauma, inniammatory joint disease (NIDJD) or any of its composite diagnoses such as degencrative joint diodoo (KTBCB) enthritis; slipped capital epiphysis; fused hip; Usteoanthilis, avasodial Hoorono, travant; old, remote osteomyelitis with an extended fracture of the period; nonunion; femoral neck fracture and trochanteric fractures of the uranage-free perfou, nonanien, remat that are unmanageable using other techniques; proximal lemur with houd involvement. fracture dislocation of the hip and correction of deformity.
Acetabular reinforcement and reconstruction rings are intended to be used in primary and Acetabular reinforoomont and rooshulum has the deficiencies of the acetabular roof, revision surgenos while the acolable leficiency, and/or protrusion as a result of the indications listed previously. The device is intended for single use.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use
(Optional Format 1-2-96)
uriani C. Provost
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
510(k) Number K040680