510(k) · Cleared
ClearedSmith & Nephew Biosure PK Interference Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew Endoscopy, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jan 30, 2009 as substantially equivalent to K080358 (Smith & Nephew Inc., Endoscopy Div., 2008) and 2 other predicates after a 53-day review. Its family tree reaches back 5 generations to 1996. 21 later devices descend from it.
- Decided
- Jan 30, 2009
- Review
- 53 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K961555 (1996). 18 ancestors in all, the oldest K915424 (1993). 21 later devices descend from it, 11 citing it directly.
- Root · 5 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 4 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 3 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 2 generations backK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
- 1 generation backK071586 Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007 · Recalled
- This deviceK083635 Smith & Nephew Biosure PK Interference ScrewSmith & Nephew Endoscopy, Inc. · 2009
- Descendant · cites it directly · 7 of its ownK133036 Apollo Suture Anchor System and Titan ScrewsAmendia, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 5 of its ownK142230 Apollo Suture Anchor System and Titan ScrewsValeris Medical · 2014 · Recalled
- Descendant · cites it directly · 2 of its ownK180573 Responsive Arthroscopy Interference Screw SystemResponsive Arthroscopy, LLC · 2018
- Descendant · 3 generations on · 1 of its ownK192810 Apollo Suture Anchor SystemValeris Medical · 2020
- Descendant · cites it directly · 1 of its ownK190892 MectaScrew PEEK Interference ScrewMedacta International S.A. · 2019
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K133036Apollo Suture Anchor System and Titan ScrewsAmendia, Inc. · 2014 · cites it directly7descendants
- K142230Apollo Suture Anchor System and Titan ScrewsValeris Medical · 2014 · 2 generations on5descendants
- K180573Responsive Arthroscopy Interference Screw SystemResponsive Arthroscopy, LLC · 2018 · cites it directly2descendants
- K192810Apollo Suture Anchor SystemValeris Medical · 2020 · 3 generations on1descendant
- K190892MectaScrew PEEK Interference ScrewMedacta International S.A. · 2019 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −4 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −3 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −2 | K061154 | Kinsa Suture Anchor | Smith & Nephew, Inc. | 2006 | — |
| −1 | K071586 | Bioraptor 2.3 PK Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2007 | 1 |
| 0 (this device) | K083635 | Smith & Nephew Biosure PK Interference Screw | Smith & Nephew Endoscopy, Inc. | 2009 | — |
| +1 | K133036 | Apollo Suture Anchor System and Titan Screws | Amendia, Inc. | 2014 | 1 |
| +2 | K142230 | Apollo Suture Anchor System and Titan Screws | Valeris Medical | 2014 | 1 |
| +1 | K180573 | Responsive Arthroscopy Interference Screw System | Responsive Arthroscopy, LLC | 2018 | — |
| +3 | K192810 | Apollo Suture Anchor System | Valeris Medical | 2020 | — |
| +1 | K190892 | MectaScrew PEEK Interference Screw | Medacta International S.A. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 5 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2026 | 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 MBI? 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 MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K080358 | Plla, HA ScrewSummary page 1…tended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: Smith & Nephew BIOSURE HA Interference Screw (K080358), Smith & Nephew BioRaptor 2.3PK Suture Anchor (K071586), and Arthrex Interference Screw (K062466) K083635… | 2008 |
| * | K071586 | Bioraptor 2.3 PK Suture AnchorSummary page 1…lowing legally marketed device in commercial distribution: Smith & Nephew BIOSURE HA Interference Screw (K080358), Smith & Nephew BioRaptor 2.3PK Suture Anchor (K071586), and Arthrex Interference Screw (K062466) K083635 Attachmen… | 2007 |
| * | K062466 | Arthrex Interference ScrewSummary page 1…rcial distribution: Smith & Nephew BIOSURE HA Interference Screw (K080358), Smith & Nephew BioRaptor 2.3PK Suture Anchor (K071586), and Arthrex Interference Screw (K062466) K083635 Attachment 2… | 2006 |
What descends from it? (21)
See all 2111 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133036 | Apollo Suture Anchor System and Titan Screws | 2014 | 7 |
| K180573 | Responsive Arthroscopy Interference Screw System | 2018 | 2 |
| K190892 | MectaScrew PEEK Interference Screw | 2019 | 1 |
| K140879 | Biosure Healicoil PK Interference Screw | 2014 | 1 |
| K093943 | Biosure Sync Tibial Fixation Device, 6MM, 8MM,10MM,12MM | 2010 | 1 |
| K253130 | Dione PEEK Screw System | 2026 | 0 |
| K230874 | Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath | 2023 | 0 |
| K230655 | PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw | 2023 | 0 |
| K202883 | Sterile bone screw (PEEK ACL screw) | 2020 | 0 |
| K151220 | Dunamis Interference Screw | 2015 | 0 |
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 13 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 5 of the 18 ancestors have a recall of any class.
- Of its descendants, K133036 (Amendia, Inc., 2014) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K080358.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, 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 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
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…
Read the full statement (195 words)
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
1iliotibial band tenodesis
Shoulder
* Capsular stabilization
- Bankart repair
- Anterior shoulder instability
- SLAP lesion repairs
- Capsular shift or capsulolabral reconstructions
* Acromilavicular separation repairs
· Deltoid repairs
* Rotator cuff tear repairs
· Biceps tenodesis
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 epicondylitis repair
* Scapholunate ligament reconstruction
· Tendon Transfers
* Carpometacarpal Joint Arthroplasty
* Carpal Ligament Reconstruction
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083635 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083635: Smith & Nephew Biosure PK Interference Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083635
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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