(63 days)
The Arthrex Bio-Composite Suture Anchor Family is intended to be used for:
Fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis.
For suture or tissue fixation in the foot, ankle, hand, wrist, elbow, shoulder, and in select maxillofacial applications where size is appropriate.
Please see indications for use statements for specific indications.
The Arthrex Bio-Composite Corkscrew is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis in, but not limited to, the following procedures:
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy.
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.
The Arthrex Bio-Composite PushLock™ is intended for fixation of suture (soft tissue) to bone in the shoulder, footlankle, knee, hand/wrist, elbow, and pelvis in the following procedures:
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.
The Arthrex Bio-Composite Tak™ is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, shoulder, elbow, and in select maxillofacial applications. Specific indications are listed below and are size appropriate per patient needs:
Stabilization and fixation of oral cranio-maxillofacial skeletal bone, Skull: mandible and maxillofacial bones, Lateral Canthoplasty, Repair of Nasal Vestibular Stenosis, Brow Lift, Temporomandibular Joint (TMJ) reconstruction, Soft tissue attachment to the parietal temporal ridge, frontal, zygoma, and perioorbital bones of the skull. Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Elbow. Reconstruction. Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder: Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Scapholunate Ligament Reconstruction, Carpal Ligament Hand/Wrist: Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, Digital Tendon Transfers.
Foot/Ankle. Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot reconstruction,
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.
The Arthrex Bio-Composite Suture Anchors Family is very similar to the predicate devices in diameter, length, and eyelet design. The difference lies in the bio-degradable material used to construct the new model. The implants will use PLLA or PLDLA combined with TCP.
The provided text describes a 510(k) submission for the Arthrex Bio-Composite Suture Anchors. This submission aims to demonstrate substantial equivalence to a previously cleared predicate device (K061863), rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics in the typical sense.
Here's an analysis based on the information provided, addressing your requested sections where applicable:
Acceptance Criteria and Device Performance (as interpreted from a 510(k) context)
For a 510(k) submission, "acceptance criteria" are generally met by demonstrating substantial equivalence to a predicate device. This means showing that the new device is as safe and effective as a legally marketed device. The "device performance" is therefore described in terms of its similarities and any minor differences to the predicate, and how those differences do not raise new questions of safety or effectiveness.
| Acceptance Criterion (for Substantial Equivalence in 510(k)) | Reported Device Performance (Comparison to Predicate K061863) |
|---|---|
| Similar Intended Use | Met: The intended uses are "Identical" as stated in the comparison table. The Arthrex Bio-Composite Suture Anchor Family is intended for "Fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis." |
| Similar Indications for Use | Largely Met, with a specified exclusion: "Identical except for the exclusion of the hip indications." The Bio-Composite Suture Anchors are not indicated for capsular and acetabular labral repair in the hip. Otherwise, specific indications (e.g., Rotator Cuff Repairs, Achilles Tendon Repair) for shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis are consistent with the predicate across the different product types (Corkscrew, PushLock, Tak). |
| Similar Technological Characteristics (Design) | Largely Met: "Screw-In, push-In Anchors: Full threaded, cannulated/non-cannulated, partially cannulated, with or without suture eyelet." This is identical to the predicate. |
| Similar Technological Characteristics (Materials) | Difference, but deemed safe: The new device uses "PLLA/TCP or PLDLA/TCP." The predicate uses "PLLA, PLDLA, PEEK, Titanium." The bio-composite materials (PLLA, PLDLA, TCP) used in the new device are stated to have "a long history of implantable use in the medical field and have been shown to be biocompatible" and are currently used in other Arthrex marketed bioabsorbable devices. This difference is considered minor and does not raise new questions of safety or effectiveness. |
| Similar Technological Characteristics (Dimensions) | Minor Differences, but within acceptable range: - Diameter: New device: "3-5.5 mm". Predicate: "2.4 - 6.5 mm". The new device falls within the predicate's range, albeit with a narrower overall range.- Length: New device: "14-14.7 mm". Predicate: "5-18.5 mm". The new device also falls within the predicate's range, with a narrower specific range.These differences are not presented as raising safety/effectiveness concerns. |
| Similar Performance Characteristics (e.g., Strength, Biocompatibility) | Implied to be met through materials and design comparison: The document states "Any differences between the Bio-Composite Suture Anchor Family and the predicate K061863 are considered minor and do not raise questions concerning safety and effectiveness." This implies that the performance (e.g., mechanical strength, degradation profile, biocompatibility) is considered equivalent despite the material change, likely supported by non-clinical testing or existing data for the composite materials, though specific test results are not detailed in this summary. The mention that the biodegradable materials have a "long history of implantable use" supports the biocompatibility aspect. |
| Similar Sterile, Single Use, Packaging, Shelf Life | Met: All are listed as "Identical" for Packaging, Sterile, and Single Use. Shelf life for PLLA/PLDLA is 2 years for both new and predicate, ensuring equivalence for relevant material types. |
Study Information
The provided document describes a 510(k) Premarket Notification which primarily relies on demonstrating substantial equivalence to a predicate device. It does not present a study (e.g., clinical trial) in the traditional sense with acceptance criteria, sample sizes, experts, or ground truth as would be the case for a novel device or a device requiring a PMA.
Therefore, for most of the requested points, the answer is "Not Applicable" or "Not provided in this 510(k) summary."
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is a 510(k) substantial equivalence submission, not a study with a test set of patient data. The "test set" here refers to a comparison of the new device's specifications against the predicate device's specifications and existing knowledge/data about the materials.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. There is no "ground truth" established by experts for a test set in this context. The determination of substantial equivalence is made by the FDA reviewer based on the information provided by the manufacturer.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set requiring adjudication in this format.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is a physical medical device (suture anchors), not an AI/software device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. The "ground truth" for a 510(k) substantial equivalence is the safety and effectiveness profile of the predicate device, as established by its clearance and general market use, and the scientific/clinical knowledge underpinning the materials and design. The new device is evaluated against this established standard.
- The sample size for the training set
- Not Applicable. There is no "training set" in the context of this 510(k) submission for a physical device.
- How the ground truth for the training set was established
- Not Applicable. No training set.
Summary of the 510(k) Process:
The key to this submission is demonstrating that the Arthrex Bio-Composite Suture Anchors are substantially equivalent to the predicate Arthrex PushLock, Tak, and Corkscrew Suture Anchors (K061863). The manufacturer achieves this by:
- Highlighting identical intended uses.
- Acknowledging minor differences in indications for use (exclusion of hip).
- Acknowledging differences in materials (new bio-composite), but justifying their safety and effectiveness due to their history of use in medical implants and other Arthrex devices.
- Showing similar design and dimensions that fall within the predicate's range or are presented as minor and not impacting safety/effectiveness.
The FDA's letter (Section 4, 5) confirms that based on the submitted information, the device is found substantially equivalent to legally marketed predicate devices. This means the device meets the "acceptance criteria" for demonstrating substantial equivalence for the purpose of market clearance via the 510(k) pathway.
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Ko 7/1/77 Psa 1/4
Arthrex SPECIAL 510(K): Arthrex Bio-Composite Suture Anchors
JUN 2 9 2007
2 510(k) Summary of Safety and Effectiveness
| Manufacturer/Sponsor | Arthrex, Inc.1370 Creekside Boulevard Naples, Florida 34108-1945 |
|---|---|
| 510(k) Contact | Mariela CabarcasRegulatory Affairs AssociateTelephone: 239/643.5553, ext 1246Fax: 239/598.5508Email: mcabarcas@arthrex.com |
| Trade Name | Arthrex Bio-Composite Suture Anchors: Arthrex Bio-CompositePushLock, Bio-Composite Tak and Bio-Composite Corkscrew. |
| Common Name | Suture Anchor. |
| Product Code -Classification Name | HWC - Screw, Fixation, BoneMBI - Fastener, Fixation, Nondegradable Soft TissueJDR - Staple, fixation, boneMAI - Fastener, Fixation, Biodegradable, Soft Tissue |
| Predicate Device | Arthrex PushLock, Tak and Corkscrew Suture Anchors: K061863 |
| Device Descriptionand Intended Use | The Arthrex Bio-Composite Suture Anchors Family is very similar tothe predicate devices in diameter, length, and eyelet design. Thedifference lies in the bio-degradable material used to construct the newmodel. The implants will use PLLA or PLDLA combined with TCP.The Arthrex Bio-Composite Suture Anchor Family is intended to beused for:Fixation of suture (soft tissue) to bone in the shoulder, foot/ankle,knee, hand/wrist, elbow, and pelvis.For suture or tissue fixation in the foot, ankle, hand, wrist, elbow,shoulder, and in select maxillofacial applications where size isappropriate.Please see indications for use statements for specific indications. |
| SubstantialEquivalence Summary | The Arthrex Bio-Composite Suture Anchor Family is substantiallyequivalent to the predicate Arthrex PushLock, Tak and Corkscrew SutureAnchors families in which the basic features and intended uses are identicalexcept for the exclusion of the hip indication. The Bio-Composite SutureAnchors are not indicated to be used for the capsular and acetabular labralrepair.Any differences between the Bio-Composite Suture Anchor Family and thepredicate K061863 are considered minor and do not raise questionsconcerning safety and effectiveness. Based on the information submitted,Arthrex, Inc. has determined that the new Bio-Composite Suture AnchorFamily is substantially equivalent to the currently marketed predicate device. |
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3 Substantial Equivalence
The fundamental scientific technology of the Arthrex Bio-Composite Suture Anchors has not changed from the previously cleared Suture Anchor Family, K061863.
The indications for use of the Arthrex Bio-Composite Suture Anchors remain the same as those cleared for the predicate PushLock, Tak, Corkscrew Suture Anchors (K061863) except for the exclusion of the hip indications. The Bio-Composite Suture Anchors are not indicated to be used for the capsular and acetabular labral repair.
The Bio-composite Suture Anchors have been developed using different biodegradable materials such as Poly (L-Lactide) (PLLA) and (PLDLA) Poly L-co-D-L-Lactide and ceramic material TriCalcium Phosphate (TCP). The biodearadable materials of the Bio-Composite Suture Anchors are currently used in the manufacturing of numerous Arthrex marketed bioabsorbable devices. The composite materials used in the construction of the Bio-Composite Suture Anchors have a long history of implantable use in the medical field and have been shown to be biocompatible.
The Arthrex Bio-Composite Suture Anchor family is substantially equivalent to the predicate device Suture Anchor family from K061863, where basic features and intended uses are the same. Any design differences between the Arthrex Bio-Composite Suture Anchors and the original Family of Suture Anchors are considered minor and do not raise questions concerning safety and effectiveness.
Based on the information submitted, Arthrex has determined that the Bio-Composite Suture Anchor Family is substantially equivalent to the cleared Suture Anchor Family, K061863.
Refer to Table 9-7 for a comparison of the similarities and differences between the cleared Arthrex Suture Anchors (K061863) and the new devices, the Arthrex Bio-Composite Suture Anchors.
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| SimilaritiesandDifferences | Arthrex Bio-CompositeSuture AnchorsThis "Special" Submission | Arthrex PushLok, Tak, andCorkscrew Suture AnchorsCLEARED, (K061863) |
|---|---|---|
| Product Code | MAI, HWC | HWC, MBI, JDR, MAI |
| 21 CFR | 888.3030888.3040 | 888.3040888.3030 |
| Design | Screw-In, push-In Anchors:Full threaded, cannulated/ non-cannulated, partiallycannulated, with or withoutsuture eyelet. | Screw-In, push-In Anchors:Full threaded, cannulated/non- cannulated, partiallycannulated, with or withoutsuture eyelet. |
| Material | PLLA/TCP or PLDLA/TCP | PLLA, PLDLA, PEEK,Titanium |
| Intended Use | Identical | Identical |
| Indications for Use | Identical except for theexclusion of the hip indications. | Fixation of suture (softtissue) to bone in theshoulder, foot/ankle,hip, knee, hand/wrist,elbow, and pelvis. For suture or tissuefixation in the foot,ankle, hip, hand, wrist,elbow, shoulder, and inselect maxillofacialapplications where sizeis appropriate. |
| Diameter | 3-5.5 mm | 2.4 - 6.5 mm |
| Length | 14-14.7 mm | 5- 18.5 mm |
| Threaded | Yes | Yes |
| Sutures | Insert molded and suppliedwith, or recommended Suture.Polyblend | Insert molded and suppliedwith, or recommendedSuture.Polyblend |
| Packaging | Identical | Identical |
| Sterile | Yes | Yes |
| Shelf Life | 2 years | 2 years- PLLA, PLDLA5 years- PEEK and Ti |
| Single Use | Yes | Yes |
- A comparison of Cleared Suture Anchor Family and the new Bio-Table 3-1 Composite Suture Anchor Family.
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Pge 4 of 4
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an eagle with its wings spread, clutching a caduceus in its talons. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 9 2007
Arthrex, Inc. % Ms. Mariela Cabarcas Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K071177 Trade/Device Name: Arthrex Bio-Composite Suture Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MBI, JDR, MAI Dated: June 5, 2007 Received: June 6, 2007
Dear Ms. Cabarcas:
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.
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.
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Page 2 - Ms. Mariela Cabarcas
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or 240-276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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pye 'fs
Arthrex SPECIAL 510(K); Arthrex Bio-Composite Suture Anchors
Indications for Use Form assala
Indications for Use
510(k) Number: Device Name:
Ko71177
Arthrex Bio-Composite Corkscrew
The Arthrex Bio-Composite Corkscrew is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis in, but not limited to, the following procedures:
| Shoulder: | Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. |
|---|---|
| Foot/Ankle: | Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy. |
| Knee: | Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. |
| Hand/Wrist: | Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction. |
| Elbow: | Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis Repair. |
| Pelvis: | Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency. |
Prescription Use _ X_AND/OR Over-The-Counter Use
Use No
(Per 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
currence of CDRH, Office of Device Evaluation (ODE) PAGE 1 of 3
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number Page 4 of 26 | L071177
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page 2/3
Arthrex SPECIAL 510(K): Arthrex Bio-Composite Sulture Anchors
Indications for Use
510(k) Number: Device Name:
| The A. A. A. S. C. C. C. C. C. CANADIC - CARDER & C. CLANDING & A CLAIM CLASS OF CLASS OF CLASS OF CLASS OF CLASS OF CLASS OF CLASS OF CLASS OF CLASS OF CLASS OF CLASS OF CLA | Company of the comments of the comments of | ||
|---|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------ | PTHE A L A Children A C A B . A . C . C . CMORE LEELERS------- | AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA11 | Company of Canadian Compress of Actually Company Company Comprehensive Company of T. |
The Arthrex Bio-Composite PushLock™ is intended for fixation of suture (soft tissue) to bone in the shoulder, footlankle, knee, hand/wrist, elbow, and pelvis in the following procedures:
| Shoulder: | Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. |
|---|---|
| Foot/Ankle: | Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy. |
| Knee: | Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. |
| Hand/Wrist: | Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction. |
| Elbow: | Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair. |
| Pelvis: | Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency. |
Prescription Use X AND/OR Over-The-Counter Use No
(Per 21 CFR 801 Subpart D) (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) PAGE 2 of 3
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Page 3 of 3
Co SPECIAL 510(K): Arthrex Bio-Composite Suture Anchors
Indications for Use
510(k) Number: Device Name:
Ko71177
Arthrex Bio-Composite Tak
The Arthrex Bio-Composite Tak™ is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, shoulder, elbow, and in select maxillofacial applications. Specific indications are listed below and are size appropriate per patient needs:
- Stabilization and fixation of oral cranio-maxillofacial skeletal bone, Skull: mandible and maxillofacial bones, Lateral Canthoplasty, Repair of Nasal Vestibular Stenosis, Brow Lift, Temporomandibular Joint (TMJ) reconstruction, Soft tissue attachment to the parietal temporal ridge, frontal, zygoma, and perioorbital bones of the skull. Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Elbow. Reconstruction. Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder: Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Scapholunate Ligament Reconstruction, Carpal Ligament Hand/Wrist: Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP
- Foot/Ankle. Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot reconstruction,
joints for all digits, Digital Tendon Transfers.
- Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
- Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.
Prescription Use X AND/OR Over-The-Counter Use N ?
(Per 21 CFR 801 Subpart D)
(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)
PAGE 3 of 3
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.