510(k) · Cleared
ClearedFlower Suture Anchor Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Flower Orthopedics Corporation · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Oct 7, 2020 as substantially equivalent to K113299 (Rog Sports Medicine, Inc., 2011) and 5 other predicates after a 355-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- Oct 7, 2020
- Review
- 355 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 7 generations to K961555 (1996). 28 ancestors in all, the oldest K931519 (1994). No later device cites it as a predicate yet.
- Root · 7 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 6 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 5 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 4 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- 3 generations backK110229 Rog Suture Anchor 5.5MM, 2.9MMRog Sports Medicine, Inc. · 2011
- 2 generations backK111590 Rog Suture Anchor, Rog Knotless Suture AnchorRog Sports Medicine, Inc. · 2011
- 1 generation backK112991 Modified Rog Suture AnchorRog Sports Medicine, Inc. · 2011
- This deviceK192949 Flower Suture Anchor SetFlower Orthopedics Corporation · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −6 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −5 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −4 | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| −3 | K110229 | Rog Suture Anchor 5.5MM, 2.9MM | Rog Sports Medicine, Inc. | 2011 | — |
| −2 | K111590 | Rog Suture Anchor, Rog Knotless Suture Anchor | Rog Sports Medicine, Inc. | 2011 | — |
| −1 | K112991 | Modified Rog Suture Anchor | Rog Sports Medicine, Inc. | 2011 | — |
| 0 (this device) | 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 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 3 | 0 |
| 2001 | 5 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2011 | 2 | 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? (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 |
|---|---|---|---|
| * | K113299 | Rog Suture AnchorSummary page 5…Trade Name 510K Primary Predicate: RoG Sports Medicine Inc. Rog Suture Anchor K113299 Additional Predicates: Arthrex, Inc. Arthrex 3.0mm SutureTak K061863… | 2011 |
| * | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilySummary page 5…ture Anchor K113299 Additional Predicates: Arthrex, Inc. Arthrex 3.0mm SutureTak K061863 RoG Sports Medicine Inc. Rog Suture Anchor 5.5mm, 2.9mm K110229 RoG Sports Medicine Inc.… | 2006 |
| * | K110229 | Rog Suture Anchor 5.5MM, 2.9MMSummary page 5…rex, Inc. Arthrex 3.0mm SutureTak K061863 RoG Sports Medicine Inc. Rog Suture Anchor 5.5mm, 2.9mm K110229 RoG Sports Medicine Inc. Rog Knotless Suture Anchor K110230 RoG Sports Medicine Inc.… | 2011 |
| * | K110230 | Rog Knotless Suture AnchorSummary page 5…Sports Medicine Inc. Rog Suture Anchor 5.5mm, 2.9mm K110229 RoG Sports Medicine Inc. Rog Knotless Suture Anchor K110230 RoG Sports Medicine Inc. Rog Suture Anchor, Rog Knotless Suture K111590… | 2011 |
| * | K111590 | Rog Suture Anchor, Rog Knotless Suture AnchorSummary page 5…Sports Medicine Inc. Rog Knotless Suture Anchor K110230 RoG Sports Medicine Inc. Rog Suture Anchor, Rog Knotless Suture K111590 Anchor RoG Sports Medicine Inc. Modified Rog Suture Anchor… | 2011 |
| * | K112991 | Modified Rog Suture AnchorSummary page 5…Rog Knotless Suture K111590 Anchor RoG Sports Medicine Inc. Modified Rog Suture Anchor K112991 Device Description The Flower Suture Anchor Set consists of FlowerAnchor, 3.0mm, FlowerAnchor, 5.0mm, and FlowerAnchor, Knotles… | 2011 |
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 24 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 7 of the 28 ancestors have a recall of any class.
- 1 other device also cites its predicate K113299.
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. 2020, 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 Flower Suture Anchor Set is intended to be used to aid arthroscopic and orthopedic reconstructive procedures needing soft tissue fixation, due to injury or degenerative disease. The FlowerAnchor, 3.0mm is indicated for use in soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows: • Shoulder indications: Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or…
Read the full statement (252 words)
The Flower Suture Anchor Set is intended to be used to aid arthroscopic and orthopedic reconstructive procedures needing soft tissue fixation, due to injury or degenerative disease.
The FlowerAnchor, 3.0mm is indicated for use in soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle 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: Scapholunate ligament reconstruction.
• Foot/Ankle indications: Tendon repair/reconstruction, hallux valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
• Elbow indications: Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction.
• Knee indications: Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure, extracapsular repair, vastus medialis obliquus (VMO) muscle advancement.
The FlowerAnchor, 5.0mm and FlowerAnchor, Knotless is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle 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, hallux 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/K192949 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192949: Flower Suture Anchor Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192949
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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