510(k) · Cleared
ClearedRing-Lok Modular Bipolar System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implants International, Ltd. · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Cleared on Feb 7, 2014 as substantially equivalent to K091967 (Medacta International S.A., 2010) and 1 other predicate after a 178-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Feb 7, 2014
- Review
- 178 days
- Class
- Class II
- Product code
- KWY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K953510 (1995). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK953510 Hip Joint Femoral (Hemi-Hip) Metal/Polymer Cemented or Uncemented…Encore Orthopedics, Inc. · 1995 · Recalled
- 3 generations backK982447 Plus Bipolar Prosthesis CocrmoPlus Orthopedics · 1998
- 2 generations backK082468 Apex Hip System Bipolar Head, Model H3-822XX and H3-828YY, XX=OD in…Omni Life Science, Inc. · 2009 · Recalled
- 1 generation backK091967 Medacta Bipolar HeadMedacta International S.A. · 2010
- This deviceK132539 Ring-Lok Modular Bipolar SystemImplants International, Ltd. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953510 | Hip Joint Femoral (Hemi-Hip) Metal/Polymer Cemented or Uncemented Prosthesis | Encore Orthopedics, Inc. | 1995 | 18 |
| −3 | K982447 | Plus Bipolar Prosthesis Cocrmo | Plus Orthopedics | 1998 | — |
| −2 | K082468 | Apex Hip System Bipolar Head, Model H3-822XX and H3-828YY, XX=OD in [MM]… | Omni Life Science, Inc. | 2009 | 23 |
| −1 | K091967 | Medacta Bipolar Head | Medacta International S.A. | 2010 | — |
| 0 (this device) | K132539 | Ring-Lok Modular Bipolar System | Implants International, Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 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 KWY? 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 KWY device
- #1 K253357 b-ONE® Bipolar Headscore 11.2 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K091967 | Medacta Bipolar HeadSummary page 2…ar Instrumentation for use with the Ring-Lok TM Modular Ri-Polar System. 5. Predicate Device Comparison Substantial equivalence is claimed to the Medacta Ri-Polar Head (K091967) and the BioPro Bi- Polar Head (K082705). The Ring-Lok TM Modular Bipolar System: * Is the same technology (design and materi… | 2010 |
| * | K082705 | Biopro Bipolar Head, Models 18130-18152Summary page 2…-Lok TM Modular Ri-Polar System. 5. Predicate Device Comparison Substantial equivalence is claimed to the Medacta Ri-Polar Head (K091967) and the BioPro Bi- Polar Head (K082705). The Ring-Lok TM Modular Bipolar System: * Is the same technology (design and material) as the predicate devices * Has t… | 2008 |
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 19 years and passes through 5 companies; a new generation was cleared every 3.9 years on median.
- 3 of the 7 ancestors have a recall of any class.
- 2 other devices also cite its predicate K091967.
How does its category compare?
All KWY devicesKWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · KWY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWY
126in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWY
180in 2025
MAUDE reports naming product code KWY, 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 | 0 | — | 25 | 370 |
| 2008 | 3 | 123 | 0 | 900 |
| 2009 | 1 | — | 24 | 961 |
| 2010 | 4 | 187 | 1 | 688 |
| 2011 | 1 | — | 0 | 758 |
| 2012 | 1 | — | 1 | 978 |
| 2013 | 2 | — | 2 | 1,148 |
| 2014 | 1 | — | 0 | 1,055 |
| 2015 | 1 | — | 0 | 1,213 |
| 2016 | 1 | — | 3 | 877 |
| 2017 | 1 | — | 2 | 826 |
| 2018 | 3 | 219 | 1 | 1,380 |
| 2019 | 5 | 126 | 1 | 1,530 |
| 2020 | 1 | — | 0 | 1,259 |
| 2021 | 0 | — | 0 | 276 |
| 2022 | 2 | — | 0 | 208 |
| 2023 | 2 | — | 0 | 178 |
| 2024 | 0 | — | 1 | 209 |
| 2025 | 1 | — | 2 | 180 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Ring-Lok Th Modular Si-Polar System is intended for use in combination with other previously cleared femoral components including the Rig-Fixtm Hip Stem (K0721 01), C-fit Performs (K(923898) or the Stability Hip Stem (K(91 5787 and K(934457) for uncemented primary or revision hemi-arthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:
* Femoral neck and trochanteric fractures of the proximal femur
* Osteonecrosis of the femoral head
* Revision procedures where other treatments or devices or these indications; have failed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132539 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132539: Ring-Lok Modular Bipolar System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132539
Report an extraction error
Are you the manufacturer?
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