510(k) Report

510(k) · Cleared

Cleared

Arthrex Titanium and Bio-Degradable (Polymer) Implants

K053338510(k) TraditionalCleared Jan 26, 200656-day reviewClass II21 CFR 888.3040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Arthrex, Inc. · HWC Screw, Fixation, Bone

Cleared on Jan 26, 2006 as substantially equivalent to K012787 (Smith & Nephew, Inc., 2002) and 2 other predicates after a 56-day review. Its family tree reaches back 1 generation to 2002.

Decided
Jan 26, 2006
Review
56 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K012787 (2002). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 2 other ancestorsK012787 · Vaporized Hydrogen Peroxide (VHP) Sterilization of Uhmwpe Components in the Reflection Actabular System (Acetabular Line · Smith & Nephew, Inc. · 2002 · recalled20002002200420062008
Other ancestors, by generation 1 generation back: 2 other ancestors K012787 · Vaporized Hydrogen Peroxide (VHP) Sterilization of Uhmwpe Components in the Reflection Actabular System (Acetabular Line · Smith & Nephew, Inc. · 2002 · recalled0
  1. Root · 1 generation backK012787 Vaporized Hydrogen Peroxide (VHP) Sterilization of Uhmwpe Components…Smith & Nephew, Inc. · 2002 · Recalled
  2. This deviceK053338 Arthrex Titanium and Bio-Degradable (Polymer) ImplantsArthrex, Inc. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K012787Vaporized Hydrogen Peroxide (VHP) Sterilization of Uhmwpe Components in the…Smith & Nephew, Inc.20021
0 (this device)K053338Arthrex Titanium and Bio-Degradable (Polymer) ImplantsArthrex, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200220
FIG. 1 — Lineage of K053338, 2002–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HWC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new HWC device

  1. #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K012787Vaporized Hydrogen Peroxide (VHP) Sterilization of Uhmwpe Components in the Reflection…
Summary page 1
…gical testing. Substantially Equivalent Devices: Arthrex is claiming substantial equivalence to sterilization processing of a competitor's products; Smith & Nephew hip (K012787), shoulder (K012788), and knee (K012778). DEPARTMENT OF HEALTH & HUMAN SERVICES…
Smith & Nephew, Inc.20021
*K012788Vaporized Hydrogen Peroxide (VHP) Sterilization of Unmwpe Components in the Cofield…
Summary page 1
…tantially Equivalent Devices: Arthrex is claiming substantial equivalence to sterilization processing of a competitor's products; Smith & Nephew hip (K012787), shoulder (K012788), and knee (K012778). DEPARTMENT OF HEALTH & HUMAN SERVICES Public H…
Smith & Nephew, Inc.2002—
*K012778Vaporized Hydrogen Peroxide (VHP) Sterilization of Uhmwpe Components in the Genesis Knee…
Summary page 1
…Devices: Arthrex is claiming substantial equivalence to sterilization processing of a competitor's products; Smith & Nephew hip (K012787), shoulder (K012788), and knee (K012778). DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service…
Smith & Nephew, Inc.2002—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 1 of the 3 ancestors has a recall of any class.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HWC

15in 2025

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
2007high 33 (2008) · low 0 (2023)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HWC

2,893in 2025

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

What is it indicated for?

The products found in the original 510(k) K971358 Bio-Interference Screw, will use the following indications for use: To provide interference fixation of bone-tendon-bone and soft tissue grafts in ACL reconstruction through arthroscopy or arthrotomy. The products found in the original 510(k) K011172 Bio-Transfix, will use the following indications for use: To provide ACL graft fixation in the femur in orthopedic procedures. The products found in the…

Read the full statement (591 words)

The products found in the original 510(k) K971358 Bio-Interference Screw, will use the following indications for use:

To provide interference fixation of bone-tendon-bone and soft tissue grafts in ACL reconstruction through arthroscopy or arthrotomy.

The products found in the original 510(k) K011172 Bio-Transfix, will use the following indications for use:

To provide ACL graft fixation in the femur in orthopedic procedures.

The products found in the original 510(k) Arthrex FASTak Suture Anchor, K971723, K000506 Arthrex Bio-FASTak, K003227 Bio-Corkscrew Suture Anchor, and K003816 Titanium Corkscrew Suture Anchor are intended to fix suture to bone, and depending on size, will use the following indications for use:

Shoulder Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromia-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction

Hand/Wrist.; Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction

Pelvis: Bladder Neck suspension for female urinary incontinence due to urethral hyper mobility or intrinsic sphincter deficiency

The products found in the original 510(k) K990340 Arthrex Tissue Tak, are intended for fixation of soft tissue to bone for reattachment of the glenoid labrum or inferior glenohumeral ligament in patients with primary or recurrent anterior dislocation or subluxation of the shoulder in association with adequate post operative immobilization.

The products found in the original 510(k) K050749 Arthrex Tak Family are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and in select maxillofacial applications and will use the following indications for use:

Skull: Stabilization and fixation of oral cranio-maxillofacial skeletal bone, 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 perloorbital bones of the skull

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, Carpal 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

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

The products found in the original 510(k), K051726 are intended to provide soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, knee, foot/ankle, and hand/wrist. This product is intended for the following indications:

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, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand! wrist

Indications for use as stated in the FDA summary.

More from Arthrex, Inc.

355 FDA decisions under this applicant name. See the company

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https://510kreport.com/device/K053338 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053338: Arthrex Titanium and Bio-Degradable (Polymer) Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053338

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026