510(k) · Cleared
ClearedRog Knotless Suture Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rog Sports Medicine, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on May 19, 2011 as substantially equivalent to K070389 (Biomet Sports Medicine, Inc., 2007) after a 113-day review. Its family tree reaches back 4 generations to 1995. 7 later devices descend from it.
- Decided
- May 19, 2011
- Review
- 113 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K943806 (1995). 13 ancestors in all, the oldest K931519 (1994). 7 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK943806 Harpoon Suture AnchorsBiomet, Inc. · 1995
- 3 generations backK012872 Resorbable Screw AnchorArthrotek, Inc. · 2001
- 2 generations backK041274 Resorbable Interference ScrewArthrotek, Inc. · 2004 · Recalled
- 1 generation backK070389 Peek Knotless AnchorsBiomet Sports Medicine, Inc. · 2007 · Recalled
- This deviceK110230 Rog Knotless Suture AnchorRog Sports Medicine, Inc. · 2011
- Descendant · cites it directly · 5 of its ownK111590 Rog Suture Anchor, Rog Knotless Suture AnchorRog Sports Medicine, Inc. · 2011
- Descendant · 2 generations on · 2 of its ownK113299 Rog Suture AnchorRog Sports Medicine, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK112991 Modified Rog Suture AnchorRog Sports Medicine, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK230517 Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm…Jarmon Medical, LLC (Dba Legends Orthopedics) · 2023
- Descendant · cites it directly · 0 of its ownK192949 Flower Suture Anchor SetFlower Orthopedics Corporation · 2020
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K111590Rog Suture Anchor, Rog Knotless Suture AnchorRog Sports Medicine, Inc. · 2011 · cites it directly5descendants
- K113299Rog Suture AnchorRog Sports Medicine, Inc. · 2011 · 2 generations on2descendants
- K112991Modified Rog Suture AnchorRog Sports Medicine, Inc. · 2011 · 2 generations on1descendant
- K230517Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends…Jarmon Medical, LLC (Dba Legends Orthopedics) · 2023 · 2 generations on0descendants
- K192949Flower Suture Anchor SetFlower Orthopedics Corporation · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K943806 | Harpoon Suture Anchors | Biomet, Inc. | 1995 | — |
| −3 | K012872 | Resorbable Screw Anchor | Arthrotek, Inc. | 2001 | — |
| −2 | K041274 | Resorbable Interference Screw | Arthrotek, Inc. | 2004 | 5 |
| −1 | K070389 | Peek Knotless Anchors | Biomet Sports Medicine, Inc. | 2007 | 1 |
| 0 (this device) | K110230 | Rog Knotless Suture Anchor | Rog Sports Medicine, Inc. | 2011 | — |
| +1 | K111590 | Rog Suture Anchor, Rog Knotless Suture Anchor | Rog Sports Medicine, Inc. | 2011 | — |
| +2 | K113299 | Rog Suture Anchor | Rog Sports Medicine, Inc. | 2011 | — |
| +2 | K112991 | Modified Rog Suture Anchor | Rog Sports Medicine, Inc. | 2011 | — |
| +2 | K230517 | Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors… | Jarmon Medical, LLC (Dba Legends Orthopedics) | 2023 | — |
| +1 | K192949 | Flower Suture Anchor Set | Flower Orthopedics Corporation | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 3 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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? (1)
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 |
|---|---|---|---|
| * | K070389 | Peek Knotless AnchorsSummary page 1…rts Medicine Knotless Suture Anchor COMMON NAME: Suture Anchor CLASSIFICATION: Class 1I (ref.: 21 CFR 888.3040); Product Code MBI PREDICATE DEVICE(S): K070389 - ALLthreadTM PEEK Suture Anchor (Biomet Sports Medicine) DESCRIPTION OF SUBJECT DEVICE: The subject device is screw-li… | 2007 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 3.8 years on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K111590 (Rog Sports Medicine, Inc., 2011) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K070389.
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. 2011, 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 RoG 5.5mm Knotless Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foottankle and knee. Specific indications are as follows: * Shoulder indications:- Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis- * Wrist/Hand indications:- Ulnar/Radial collateral ligament reconstruction…
Read the full statement (114 words)
The RoG 5.5mm Knotless Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foottankle and knee. Specific indications are as follows:
* Shoulder indications:- Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis-
* Wrist/Hand indications:- Ulnar/Radial collateral ligament reconstruction, scapholunate ligament reconstruction.
* Foot/Ankle indications:- Achilles tendon repair/reconstruction, hallax valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
* Elbow indications:- Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction, lateral epicondylitis repair.
* Knee indications:- Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair. iliotibial band tenodesis, joint capsule closure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110230 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110230: Rog Knotless Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110230
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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