← Product Code [MBI](/productcode/MBI) · K253027 # Anchor with Fiber Wire and Disposable Inserter (K253027) _Ortobio S.A. · MBI · May 6, 2026 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K253027 ## Device Facts - **Applicant:** Ortobio S.A. - **Product Code:** [MBI](/productcode/MBI.md) - **Decision Date:** May 6, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Indications for Use The Ortobio Anchor with Fiber Wire and Disposable Inserter is intended to be used for suture or tissue fixation in the elbow, shoulder, hand, wrist, foot, ankle and knee. Specific indications are listed below: • Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction • Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio- Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction • Hand/Wrist: Scapholunate Ligament 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, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty) • 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. ## Device Story Device consists of titanium alloy anchor with external threads and hexagonal head; preloaded with UHMWPE suture; preassembled into disposable applicator (stainless steel shaft, polypropylene handle). Used by surgeons in orthopedic procedures (elbow, shoulder, hand, wrist, foot, ankle, knee) for soft tissue-to-bone fixation. Surgeon inserts anchor into bone; suture secures tissue to anchor. Provides mechanical fixation for ligament/tendon repairs. MR Conditional. Single-use, sterile. ## Clinical Evidence No clinical data included. Bench testing only: mechanical performance (insertion torque, inclined insertion, quasi-static/inclined/post-fatigue pullout) compared to predicate; MR compatibility testing; biocompatibility per ISO 10993-1; sterilization validation per ISO 11135; shelf-life stability testing. ## Technological Characteristics Anchor: Titanium alloy (ASTM F136). Suture: UHMWPE (size 2). Applicator: Stainless steel (AISI 304) shaft, polypropylene handle. Disposable needles: Stainless steel (ASTM F899). MR Conditional. Sterile, single-use. Mechanical fixation via threaded anchor and suture eyelet. ## Regulatory 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. ## Predicate Devices - Suture Anchors - HTA Headless Titanium Anchor and ZIP Anchors ([K223114](/device/K223114.md)) ## Reference Devices - Parcus V-lox Titanium Suture Anchors ([K201083](/device/K201083.md)) - Parcus Miti Suture Anchors ([K201083](/device/K201083.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FDA U.S. FOOD & DRUG ADMINISTRATION May 6, 2026 Ortobio S.A. Tatiana Jabor Botura Regulatory Affairs Specialist PR Serviços Regulatórios Administrativos Ltda Edifício Pórtico Sul - R. José Jaime Delibo, 160, Nova Aliança Ribeirão Preto, SP 14026-563 Brazil Re: K253027 Trade/Device Name: Anchor with Fiber Wire and Disposable Inserter Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: April 07, 2026 Received: April 07, 2026 Dear Tatiana Jabor Botura: 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K253027 - Tatiana Jabor Botura Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 809; medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory- {2} K253027 - Tatiana Jabor Botura Page 3 assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, CHRISTOPHER FERREIRA -S Christopher Ferreira, M.S. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K253027 | ? | | Please provide the device trade name(s). | | ? | | Anchor with Fiber Wire and Disposable Inserter | | | | Please provide your Indications for Use below. | | ? | | The Ortobio Anchor with Fiber Wire and Disposable Inserter is intended to be used for suture or tissue fixation in the elbow, shoulder, hand, wrist, foot, ankle and knee. Specific indications are listed below: • Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction • Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio- Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction • Hand/Wrist: Scapholunate Ligament 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, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty) • 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. | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | | Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☐ Adults (22 years old and greater) | ? | {4} Traditional510(k) Anchor with Fiber Wire and Disposable Inserter 510(k) Summary ADMINISTRATIVE INFORMATION Sponsor/Manufacturer Name Ortobio S.A. Av. Mauá, 1133 - Zona 03, Maringá - PR, 87050-020 Phone: +55 (44) 3269-5045 Consultants Tatiana Jabor Botura and Letícia Teixeira Regulatory Affairs Specialists PR Serviços Regulatórios Administrativos Ltda Email: tatiana@passarini.com.br Telephone +55 (16) 988280027 Date Prepared August 25, 2025 DEVICE NAME AND CLASSIFICATION Trade/ Proprietary Name Anchor with Fiber Wire and Disposable Inserter Common Name Bone Anchor Classification Name Fastener, Fixation, Nondegradable, Soft Tissue Product Code MBI Classification Regulation 21 CFR 888.3040, Class II Review Panel Orthopedic PREDICATE DEVICE INFORMATION Predicate Devices K223114 - Suture Anchors - HTA Headless Titanium Anchor and ZIP Anchors Reference Device K201083 - Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors Indications for use The Ortobio Anchor with Fiber Wire and Disposable Inserter is intended to be used for suture or tissue fixation in the elbow, shoulder, hand, wrist, foot, ankle and knee. Specific indications are listed below: - Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction Ortobio S.A {5} Traditional510(k) Anchor with Fiber Wire and Disposable Inserter - Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction - Hand/Wrist: Scapholunate Ligament 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, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty) - 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. # Subject Device Description The Fiber Wire Anchor with Disposable Applicator is a sterile, single-use medical device composed of a titanium alloy anchor featuring an external threaded portion and a hexagonal head with a central hole designed for suture thread passage. The product is packaged with one or two preloaded non-absorbable sutures and is preassembled into a disposable applicator. Optional configurations include disposable suture needles. The applicator is comprised of a stainless-steel shaft (AISI 304), a polypropylene handle, and an O-ring located at the handle's distal end. The suture thread is made of ultra-high molecular weight polyethylene (UHMWPE), size 2 (0.5 mm). Disposable needles are made of stainless steel (ASTM F899). The anchor is intended for the fixation of soft tissue to bone and is typically used in ligament and tendon repair procedures in the shoulder, foot, elbow, ankle, hand, and wrist. The anchor is manufactured from titanium alloy in accordance with ISO 5832-3:1997 – Implants for Surgery – Metallic Materials – Part 3: Wrought Titanium 6-Aluminum 4-Vanadium Alloy. Ortobio S.A {6} Traditional510(k) Anchor with Fiber Wire and Disposable Inserter # Substantial Equivalence A comparison between the subject device and predicates is presented in the table below: Table 1. Substantial equivalence | Trade Name information | Subject Device | Predicate Device | Reference Predicate | Equivalent Discussion | | --- | --- | --- | --- | --- | | | Anchor with Fiber Wire and Disposable Inserter | Suture Anchors - HTA Headless Titanium Anchor and ZIP Anchors | Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors | | | | Ortobio | GM dos Reis | Parcus Medical, LLC | - | | K number | - | K223114 | K201083 | - | | Regulation Number | 21 CFR 888.3040 | 21 CFR 888.3040 | 21 CFR 888.3040 | Equivalent | | Product Code | MBI | MBI | MBI | Equivalent | | Classification Name | Fastener, Fixation, Nondegradable, Soft Tissue | Fastener, Fixation, Nondegradable, Soft Tissue | Fastener, Fixation, Nondegradable, Soft Tissue | Equivalent | | Class | II | II | II | Equivalent | | Indications for Use | The Ortobio Anchor with Fiber Wire and Disposable Inserter is intended to be used for suture or tissue fixation in the elbow, shoulder, hand, wrist, foot, ankle and knee. Specific indications are listed below:Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament ReconstructionShoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral ReconstructionHand/Wrist: Scapholunate Ligament 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, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstructionKnee: Medial Collateral | The Suture Anchors - HTA Headless Titanium Anchor and ZIP Anchors are indicated to be used for suture or tissue fixation in the elbow, shoulder, hand, wrist, foot, ankle, knee, and hip. Specific indications are listed below:Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament ReconstructionShoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral ReconstructionHand/Wrist: Scapholunate Ligament 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, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstructionKnee: Medial Collateral | The Parcus Miti Suture Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications:Shoulder: Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.Foot/Ankle: Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament RepairElbow: Tennis Elbow Repair, Biceps Tendon Reattachment. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.The Parcus V-loxTM Titanium Suture Anchors are indicated for attachment of soft tissue to bone. This product is intended | Equivalent | Ortobio S.A {7} Traditional 510(k) Anchor with Fiber Wire and Disposable Inserter | | Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis | Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hip: Capsular repair, acetabular labral repair. | for the following indications: Shoulder: Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair. Elbow: Tennis Elbow Repair, Biceps Tendon Reattachment. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC. Hip: Acetabular Labral Repair | | | --- | --- | --- | --- | --- | | Anchor Diameter | ø1,7 mm; ø 1,9 mm, 2,0 mm; ø2,8 mm; ø4,0 mm; ø5,0 mm; ø5,5 mm | ø1,7 mm; ø2,2 mm; ø2,7 mm; ø3,5 mm and ø5,0 mm | Miti Suture Anchor: ø 2.0mm, ø 2.5mm and ø 3.5mm V-lox Titanium Suture Anchor: ø4.5mm, ø 5.0mm, ø 5.5mm and ø 6.5mm. | The specifications and dimensions of the device in question are within the range of the predicate and reference devices. Minor differences in dimensions do not raise any safety or efficacy concerns. | | Suture (USP) | #2; #2-0 | #1; #2; #0; #2-0; #3-0; #4-0 | 3-0 and #2 | Equivalent | | Anchor Material | Titanium (ASTM F136) | Titanium (ASTM F136) | Titanium (ASTM F136) | Equivalent | | Suture Material | UHMWPE | UHMWPE | UHMWPE | Equivalent | | Sterilization | Sterile | Sterile | Sterile | Equivalent | | Use | Single use | Single use | Single use | Equivalent | | Principle of operation | Fixation of soft tissue to the bone | Fixation of soft tissue to the bone | Fixation of soft tissue to the bone | Equivalent | ## Comparison of Technological Characteristics with the Predicate Device The subject device, Ortobio Anchor with Fiber Wire and Disposable Inserter, is substantially equivalent in indications and design principles to the predicate and reference devices. The subject and predicate devices have equivalent intended use and share the same principle of operation for Ortobio S.A Page 4 of 4 {8} Traditional510(k) Anchor with Fiber Wire and Disposable Inserter soft tissue fixation to bone. They are all manufactured from titanium alloy (ASTM F136) and use UHMWPE sutures fixed by integrated eyelets, provided sterile and single use. The subject device dimensions and suture sizes are within the range of the predicate and reference devices. These differences do not raise new issues of safety or effectiveness. Any difference in technological characteristics do not raise new issues of safety or efficacy. No clinical data was included in this submission ## Non-clinical performance data This submission was prepared in accordance with the FDA Guidance "Bone Anchors - Premarket Notification (510(k)) Submissions" and the "Class II Special Controls Guidance Document: Surgical Sutures". The Ortobio Anchor with Fiber Wire and Disposable Inserter was evaluated for use in the MR environment and determined to be MR Conditional, based on testing performed in accordance with the FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" and applicable ASTM standards. Worst-case devices were tested for magnetically induced force, torque, RF heating, and image artifact, and the results established the MR system conditions suitable for safe use. Performance testing endpoints included insertion torque, inclined insertion, quasi-static pullout, inclined pullout, and post-fatigue pullout, all performed in accordance with FDA guidance and ASTM standards. Statistical analysis using the TOST method and non-inferiority evaluation demonstrated that the performance of the Ortobio anchors is equivalent or not inferior to the predicate HTA Headless Titanium Anchor (K223114). The results consistently confirmed that no significant differences exist between the subject and predicate devices, supporting the conclusion of substantial equivalence in mechanical performance Biological evaluation endpoints were selected in accordance with ISO 10993-1, considering the chemical characteristics of the device, as well as the nature, frequency, and duration of body contact associated with the intended use. Sterilization was validated according to ISO 11135:2014 to achieve a SAL of $10^{-6}$, with routine control and monitoring parameters established. Shelf life was supported by accelerated aging testing, demonstrating stability of the device for five years. Ortobio S.A {9} Traditional510(k) Anchor with Fiber Wire and Disposable Inserter ## Conclusion The documentation submitted in this premarket notification demonstrates that Anchor with Fiber Wire and Disposable Inserter has comparable features and performance and, therefore, is substantially equivalent to the predicate and reference device. Ortobio S.A Page 6 of 4 --- **Source:** [https://fda.innolitics.com/device/K253027](https://fda.innolitics.com/device/K253027) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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