510(k) · Cleared
ClearedArthroscopic Surgical Instruments - Interference Screw Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · HWC Screw, Fixation, Bone
Cleared on Nov 20, 2012 as substantially equivalent to K083226 (Smith & Nephew Endoscopy, Inc., 2009) and 5 other predicates after an 88-day review. Its family tree reaches back 6 generations to 1996.
- Decided
- Nov 20, 2012
- Review
- 88 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 6 generations to K961555 (1996). 22 ancestors in all, the oldest K915424 (1993). No later device cites it as a predicate yet.
- Root · 6 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 5 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 4 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 3 generations backK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
- 2 generations backK071586 Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007 · Recalled
- 1 generation backK083226 Smith & Nephew Peek Interference ScrewSmith & Nephew Endoscopy, Inc. · 2009
- This deviceK122596 Arthroscopic Surgical Instruments - Interference Screw SystemsSmith & Nephew, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −5 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −4 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −3 | K061154 | Kinsa Suture Anchor | Smith & Nephew, Inc. | 2006 | — |
| −2 | K071586 | Bioraptor 2.3 PK Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2007 | 1 |
| −1 | K083226 | Smith & Nephew Peek Interference Screw | Smith & Nephew Endoscopy, Inc. | 2009 | — |
| 0 (this device) | K122596 | Arthroscopic Surgical Instruments - Interference Screw Systems | Smith & Nephew, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
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 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K083226 | Smith & Nephew Peek Interference ScrewSummary page 1…-510(k) Clearance Date Smith & Nephew PEEK Interference Screws K083226 1/30/2009 Smith & Nephew Biosure PK Interference Screw K083635 1/30/2009 Smith & Nep… | 2009 |
| * | K083635 | Smith & Nephew Biosure PK Interference ScrewSummary page 1…Clearance Date Smith & Nephew PEEK Interference Screws K083226 1/30/2009 Smith & Nephew Biosure PK Interference Screw K083635 1/30/2009 Smith & Nephew HA-PLA Interference Screw K002274 3/7/2001 Smith & Nep… | 2009 |
| * | K002274 | Smith & Nephew Suture Hapla Interference ScrewSummary page 1…1/30/2009 Smith & Nephew Biosure PK Interference Screw K083635 1/30/2009 Smith & Nephew HA-PLA Interference Screw K002274 3/7/2001 Smith & NephewCannu-Flex InterfereniceScrews K(921481 8/24/1993 Smith & Nep… | 2001 |
| * | K921481 | Interference-Cannu-Flex/Silk Screws-Screw DR/G WirSummary page 1…1/30/2009 Smith & Nephew HA-PLA Interference Screw K002274 3/7/2001 Smith & NephewCannu-Flex InterfereniceScrews K(921481 8/24/1993 Smith & NephewBioabsorbable Interference Screw K(984320 1/28/1999 Smith & Neph… | 1993 |
| * | K984320 | Bioabsorbable Interference ScrewsSummary page 1…3/7/2001 Smith & NephewCannu-Flex InterfereniceScrews K(921481 8/24/1993 Smith & NephewBioabsorbable Interference Screw K(984320 1/28/1999 Smith & Nephew RCI Fixation Screws 0(92945 9/1/1999… | 1999 |
| * | K992945 | Rci Fixation Screws (with Assorted Sizes) Our reading of the summary gave K092945, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Smith & Nephew RCI Fixation Screws”. | 1999 |
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?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 6 of the 22 ancestors have a recall of any class.
- 3 other devices also cite its predicate K083226.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
Smith & Nephew Arthroscopic Surgical Instruments-Interference Screw Systems are surgical instruments used in arthroscopic surgery to facilitate the implantation of Interference Screw Systems for their cleared Indications for Use. The Smith & Nephew PEEK Interference Screws are indicated for the reattachment of ligament, tendon or soft tissue to bone for the following: Shoulder: Bankart Repair, Anterior Shoulder Instability, SLAP lesion repairs, Capsular…
Read the full statement (551 words)
Smith & Nephew Arthroscopic Surgical Instruments-Interference Screw Systems are surgical instruments used in arthroscopic surgery to facilitate the implantation of Interference Screw Systems for their cleared Indications for Use.
The Smith & Nephew PEEK Interference Screws are indicated for the reattachment of ligament, tendon or soft tissue to bone for the following:
Shoulder:
Bankart Repair, Anterior Shoulder Instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstruction, Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis
Foot/Ankle:
Hhllux Valgus, Lateral stabilization, Medial stabilization, Achilles Tendon repair/recon, Midfoot reconstruction, Metatarsal Ligament/tendon repair, Bunionectomy, Flexor Hullucis Longus repair, Tendon Transfers.
Elbow/Hand/Wrist:
Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Recon, Lateral Epicondylitis Repair, Scapholunate Ligament Recon, Tendon Transfers, Carpomnetacarpal Joint Arthroplasty, Carpal Ligament Recon/Repair
Knee:
Medial or Lateral Collateral ligament, Posterior oblique ligament, Vasus medialis obliquous advancement, iliotibial band tenodesis, ACL Repairs, MCL Repairs, LCL Repairs, Patellar tendon repair, Posterior Oblique ligament repair.
Smith & Nephew Arthroscopic Surgical Instruments-Interference Screw Systems are surgical instruments used in arthroscopic surgery to facilitate the implantation of Interference Screw Systems for their cleared Indications for Use.
The Smith & Nephew BIOSURE PK Interference Screws are indicated for the reattachment of ligament, tendon, soft tissue, or bone to bone during cruciate ligament reconstruction surgeries of the knee. All screws with a diameter of 9mm or less and a length of 25mm or less are also intended for use in the following procedures:
Knee
ACL Repairs
PCL Repairs
Extra-capsular repairs
Medial collateral ligament
Lateral collateral ligament
Posterior oblique ligament
Patellar realignment and tendon repairs
Vastus medialis obliquous advancement
Iliotibial band t~nodesis
Shoulder
Capsular stabilization
Bankart repair
Anterior shoulder instability
SLAP lesion repairs
Capsular shift or capsulolabral reconstructions
Acromioclavicular separation repairs
Deltoid repairs
Rotator cuff tear repairs
Biceps tenodesjs
Foot and Ankle
Hallux valgus repairs
Medial or lateral instability repairs/reconstructions
Achilles tendon repairs/reconstructions
Midfoot reconstructions
Metatarsal ligament/tendon repairs/reconstructions
Bunionectomy
Flexor Hullucis Longus (FLH)
Tendon Transfers.
Elbow, Wrist, and Hand
Biceps tendon reattachment
Ulnar or radial collateral ligament reconstructions
Lateral e picondylitis repair
Scapholunate ligament reconstruction
Tendon Transfers
Carpometacarpal Joint Arthroplasty
Carpal Ligament Reconstruction
Smith & Nephew Arthroscopic Surgical Instruments-Interference Screw Systems are surgical instruments used in arthioscopic surgery to facilitate the implantation of Interference Screw Systems for their cleared Indications for Use.
The Smith & Nephew HA-PLA Interference Screw is indicated for fixation of bone-tendon-bone or soft tissue grafts during anterior or posterior cruciate ligament reconstruction surgery.
Smith & Nephew Arthroscopic Surgical Instruments-nterference Screw Systems are surgical instruments used in arthroscopic surgery to facilitate the implantation of Interference Screw Systems for their cleared Indications for Use.
The Cannu-Flex Silk Screw is an Interference Screw, indicated for tendon/ligament graft fixation.
Smith & Nephew Artoscopic Surgical Instruments-Interference Screw Systems are surgical instruments used in arthroscopic surgery to facilitate the implantation of Interference Screw Systems for their cleared Indications for Use.
1. The Bioabsorbable Interference Screw is used for fixation of bone-tendon-bone or soft-tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.
2. The screw is indicated for single use only.
Smith & Nephew Arthroscopic Surgical Instruments-Interference Screw Systems are surgical instruments used in arthroscopic surgery to facilitate the implantation of Interference Screw Systems for their cleared Indications for Use;
RCI Fixation Screws are used for interference fixation of Bone-Tendon-Bone or soft tissue grafts in anterior or posterior cruciate ligament reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122596 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122596: Arthroscopic Surgical Instruments - Interference Screw Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122596
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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